Clinical Trials List
Protocol NumberD702FC00001
Not yet recruiting
2024-11-01 - 2031-06-30
Phase III
Recruiting8
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
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Trial Applicant
-
Sponsor
Adlai Nortye USA Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chia-Cheng Tseng Division of Thoracic Medicine
- 黃國棟 Division of Thoracic Medicine
- 鍾聿修 Division of Thoracic Medicine
- 林理涵 Division of Radiology
- 張晃智 Division of Thoracic Medicine
- 林孟志 Division of Thoracic Medicine
- 陳彥豪 Division of Hematology & Oncology
- 黃詩喻 Division of Hematology & Oncology
- Shau-Hsuan Li Division of Hematology & Oncology
- 賴建豪 Division of Thoracic Medicine
- 王逸熙 Division of Thoracic Medicine
- 李易濰 Division of Radiology
- 趙東瀛 Division of Thoracic Medicine
- 郭明濬 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李玫萱 Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- 莊政皓 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shang-Wen Chen Division of Hematology & Oncology
- 陳冠宇 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
- 黃文聰 Division of Hematology & Oncology
- 林正耀 Division of Hematology & Oncology
- 蕭聖諺 Division of Hematology & Oncology
- 陳彥勳 Division of Hematology & Oncology
- 曹朝榮 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 枋岳甫 Division of Infectious Disease
- Shih-Hong Li Division of Hematology & Oncology
- 吳教恩 Division of Hematology & Oncology
- 柯皓文 Division of Hematology & Oncology
- Ping-Chih Hsu Division of Hematology & Oncology
- Chih-Hsi Kuo Division of Hematology & Oncology
- 黃宗楨 Division of Hematology & Oncology
- Chih-Hung Chen Division of Hematology & Oncology
- Chih-Liang Wang Division of Hematology & Oncology
- 邱立忠 Division of Thoracic Medicine
- 林定佑 Division of Hematology & Oncology
- Chien-Ying Liu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- JENG-SEN TSENG Division of Thoracic Medicine
- 李柏昕 Division of Thoracic Medicine
- YEN-HSIANG HUANG Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
kang-Yun LEE
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
Objectives
To evaluate the safety and tolerability of AN4005 in subjects with advanced tumors and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
• To further evaluate the safety and tolerability of AN4005 in selected indications at two dose levels in the expansion phase
Test Drug
injection
Active Ingredient
Rilvegostomig
Pembrolizumab
Pembrolizumab
Dosage Form
270
270
270
Dosage
750MG
100MG
100MG
Endpoints
1. By evaluating overall survival (OS), demonstrate the efficacy of rilvegostomig plus chemotherapy compared to pembrolizumab plus chemotherapy.
2. By evaluating progression-free survival (PFS), demonstrate the efficacy of rilvegostomig plus chemotherapy compared to pembrolizumab plus chemotherapy.
2. By evaluating progression-free survival (PFS), demonstrate the efficacy of rilvegostomig plus chemotherapy compared to pembrolizumab plus chemotherapy.
Inclution Criteria
Age
1. Participants must be ≥ 18 years old at the time of signing the Independent Subject Consent Form (ICF).
Participant Type and Disease Characteristics
2. Histological or cytological data showing non-squamous NSCLC.
Note: Tumors with mixed adenosquamous histology are eligible if the trial administrator determines they should be treated as non-squamous tumors.
3. Stage IV mNSCLC unsuitable for curative treatment (according to the American Joint Committee on Cancer, 8th edition).
4. Non-sensitive EGFR mutations (including but not limited to exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations), and ALK and ROS1 recombinations.
Note: Testing should be performed locally; if this is not possible, central testing is permitted. Central EGFR, ALK, and/or ROS1 test results obtained during other AstraZeneca trial screenings may be used.
5. As part of standard local practice, testing for any other oncogenes of active drivers of locally approved targeted 1L therapy should be performed, showing no recorded tumor somatic mutations. Note: If not part of standard local practice, additional somatic mutation testing is not required.
6. WHO/ECOG performance status of 0 or 1, with no deterioration within 2 weeks prior to the screening baseline and prior to randomization.
7. Minimum life expectancy of 12 weeks.
8. Acceptable tumor specimens should be provided, in accordance with the definitions in the Pathology Manual and Laboratory Manual and the compilation in Section 8.8, to confirm tumor PD-L1 expression (TC) ≥ 1% using the VENTANA PD-L1 (SP263) assay at the central laboratory designated by the trial commissioner prior to randomization. Participants with undetermined PD-L1 status or a TC < 1% are ineligible for the trial. Note: If PD-L1 status was assessed using the VENTANA PD-L1 (SP263) assay at the same central laboratory as part of screening in another AstraZeneca trial, this test result may be used if the specimen meets the eligibility criteria.
9. At the baseline period, there must be at least one lesion that meets the RECIST 1.1 target lesion (TL) criteria and has not previously received radiation exposure, and whose longest diameter (≥ 10 mm) can be accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at the baseline period, suitable for accurate repeat measurements.
10. Adequate organ and bone marrow function, as defined in Table 4:
Weight
11. Minimum weight 30 kg.
Sexual Intercourse and Contraception/Barrier Requirements
12. The contraceptive method used by participants should be consistent with the methods of contraception used by clinical trial participants under local regulations; see below and Appendix G for more details.
13. Female participants of childbearing potential:
(a) Pregnancy tests must be negative at screening and before day 1 of each trial treatment.
(b) If engaging in sexual intercourse with an unsterilized male partner, at least one highly effective method of contraception must be used from screening until 4 months after the last blinded trial treatment and 6 months after the last chemotherapy dose (unless local prescribing information requires a longer duration).
(c) From screening until 4 months after the last blinded trial treatment and 6 months after the last chemotherapy dose (unless local prescribing information requires a longer duration), the unsterilized male partner of a female participant of childbearing potential must use a male condom with spermicide (if unavailable, a male condom without spermicide is acceptable). Periodic abstinence, the rhythm method, and withdrawal are unacceptable methods of contraception.
(d) From the date of screening until 4 months after the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration), breastfeeding and egg donation or collection for personal use are prohibited.
14. Unsterilized male participants who have sexual intercourse with fertile female partners:
(a) From the date of screening until 4 months after the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration), unsterilized male participants who are not abstaining and wish to have sexual intercourse with fertile female partners must use male condoms with spermicide (if unavailable, male condoms without spermicide are acceptable). Periodic abstinence, the rhythm method, and withdrawal are unacceptable methods of contraception.
(b) The female partner (of fertility) of a male participant must also use at least one highly effective method of contraception throughout the trial participation period (see Appendix G) until at least 4 months after the male partner received the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration).
(c) During the trial, and until 4 months after the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration), the male participant should avoid impregnating another person or donating sperm.
Informed Consent
15. Able to provide a signed participant consent form as described in Appendix A, including compliance with the requirements and restrictions set forth in the ICF and this CSP.
16. Provide a signed and dated written participant consent form for selective genetic research information (see Appendix D 2) before collecting specimens for selective genetic research to support the Genomics Project.
Other Inclusion Criteria
17. All races, sexes, and ethnicities are eligible to participate in this trial.
1. Participants must be ≥ 18 years old at the time of signing the Independent Subject Consent Form (ICF).
Participant Type and Disease Characteristics
2. Histological or cytological data showing non-squamous NSCLC.
Note: Tumors with mixed adenosquamous histology are eligible if the trial administrator determines they should be treated as non-squamous tumors.
3. Stage IV mNSCLC unsuitable for curative treatment (according to the American Joint Committee on Cancer, 8th edition).
4. Non-sensitive EGFR mutations (including but not limited to exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations), and ALK and ROS1 recombinations.
Note: Testing should be performed locally; if this is not possible, central testing is permitted. Central EGFR, ALK, and/or ROS1 test results obtained during other AstraZeneca trial screenings may be used.
5. As part of standard local practice, testing for any other oncogenes of active drivers of locally approved targeted 1L therapy should be performed, showing no recorded tumor somatic mutations. Note: If not part of standard local practice, additional somatic mutation testing is not required.
6. WHO/ECOG performance status of 0 or 1, with no deterioration within 2 weeks prior to the screening baseline and prior to randomization.
7. Minimum life expectancy of 12 weeks.
8. Acceptable tumor specimens should be provided, in accordance with the definitions in the Pathology Manual and Laboratory Manual and the compilation in Section 8.8, to confirm tumor PD-L1 expression (TC) ≥ 1% using the VENTANA PD-L1 (SP263) assay at the central laboratory designated by the trial commissioner prior to randomization. Participants with undetermined PD-L1 status or a TC < 1% are ineligible for the trial. Note: If PD-L1 status was assessed using the VENTANA PD-L1 (SP263) assay at the same central laboratory as part of screening in another AstraZeneca trial, this test result may be used if the specimen meets the eligibility criteria.
9. At the baseline period, there must be at least one lesion that meets the RECIST 1.1 target lesion (TL) criteria and has not previously received radiation exposure, and whose longest diameter (≥ 10 mm) can be accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at the baseline period, suitable for accurate repeat measurements.
10. Adequate organ and bone marrow function, as defined in Table 4:
Weight
11. Minimum weight 30 kg.
Sexual Intercourse and Contraception/Barrier Requirements
12. The contraceptive method used by participants should be consistent with the methods of contraception used by clinical trial participants under local regulations; see below and Appendix G for more details.
13. Female participants of childbearing potential:
(a) Pregnancy tests must be negative at screening and before day 1 of each trial treatment.
(b) If engaging in sexual intercourse with an unsterilized male partner, at least one highly effective method of contraception must be used from screening until 4 months after the last blinded trial treatment and 6 months after the last chemotherapy dose (unless local prescribing information requires a longer duration).
(c) From screening until 4 months after the last blinded trial treatment and 6 months after the last chemotherapy dose (unless local prescribing information requires a longer duration), the unsterilized male partner of a female participant of childbearing potential must use a male condom with spermicide (if unavailable, a male condom without spermicide is acceptable). Periodic abstinence, the rhythm method, and withdrawal are unacceptable methods of contraception.
(d) From the date of screening until 4 months after the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration), breastfeeding and egg donation or collection for personal use are prohibited.
14. Unsterilized male participants who have sexual intercourse with fertile female partners:
(a) From the date of screening until 4 months after the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration), unsterilized male participants who are not abstaining and wish to have sexual intercourse with fertile female partners must use male condoms with spermicide (if unavailable, male condoms without spermicide are acceptable). Periodic abstinence, the rhythm method, and withdrawal are unacceptable methods of contraception.
(b) The female partner (of fertility) of a male participant must also use at least one highly effective method of contraception throughout the trial participation period (see Appendix G) until at least 4 months after the male partner received the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration).
(c) During the trial, and until 4 months after the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration), the male participant should avoid impregnating another person or donating sperm.
Informed Consent
15. Able to provide a signed participant consent form as described in Appendix A, including compliance with the requirements and restrictions set forth in the ICF and this CSP.
16. Provide a signed and dated written participant consent form for selective genetic research information (see Appendix D 2) before collecting specimens for selective genetic research to support the Genomics Project.
Other Inclusion Criteria
17. All races, sexes, and ethnicities are eligible to participate in this trial.
Exclusion Criteria
Medical Conditions
1. In the opinion of the trial administrator, any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active bleeding disorders, persistent or active known infections; ILD (any grade), severe chronic gastrointestinal disease associated with diarrhea (e.g., active inflammatory bowel disease), active non-infectious skin disease requiring systemic treatment (including any grade of rash, urticaria, dermatitis, ulcers, or psoriasis), mental illness/social status, substance abuse, or major heart disease, which the trial administrator deems unsuitable for participation in the trial or will affect adherence to the trial protocol.
2. History of organ transplantation.
3. Having an active or previously documented autoimmune or inflammatory disease requiring long-term steroid or other immunosuppressive therapy.
4. History of other primary malignancies, excluding malignancies that have received curative treatment, have no known active disease for ≥ 2 years prior to the first dose of trial treatment, and have a very low potential risk of recurrence. Exceptions include fully excised non-melanoma skin cancer and in situ disease that has received curative treatment.
5. Presence of small cell and neuroendocrine histological components.
6. Persistent toxicity due to prior anticancer therapy (Common Adverse Event Evaluation Criteria (CTCAE) ≥ Grade 2), excluding alopecia. Participants with the following chronic, stable Grade 2 toxicities (defined as not worsening to > Grade 2 for at least 3 months prior to the first dose of trial treatment and managed with standard of care [SoC]) as determined by the trial administrator may be included, such as:
(a) Chemotherapy-induced neuropathy.
(b) Fatigue.
(c) Vitiligo.
(d) Endocrine disorders controlled by alternative hormone therapy.
(e) Participants may be included if the trial administrator believes that the participant's irreversible toxicity is not reasonably expected to worsen with trial treatment (e.g., hearing loss).
7. Spinal cord compression and/or leptomeningeal carcinoma.
8. Brain metastases, unless asymptomatic, stable, and not requiring steroids or antiepileptic drugs for at least 7 days prior to randomization. There must be at least a 2-week interval between the completion of local treatment (brain radiation therapy or surgery) and randomization. Participants must have recovered from acute toxicities of radiation therapy (e.g., signs of dizziness and increased intracranial pressure) or surgery prior to randomization.
9. Active primary immunodeficiency/active infectious disease:
• Known active hepatitis A.
• Acute hepatitis B infection (anti-HBc IgM positive) or chronic hepatitis B infection with HBV DNA ≥ 2000 IU/ml.
Participants with chronic hepatitis B infection and HBV DNA < 2000 IU/ml may be included, provided they receive antiviral prophylaxis and/or their HBV status is monitored, as shown in Figure 3.
• Active hepatitis C infection (positive anti-HCV antibody and detectable HCV RNA) or positive anti-HCV antibody and undetectable HCV RNA within 12 weeks of HCV treatment.
**Participants who are positive for anti-HCV antibodies and whose HCV RNA has been undetectable for at least 12 weeks due to successful treatment or spontaneous clearance of HCV infection are eligible to participate. These participants do not need to be tested for HCV RNA periodically during the study unless clinically necessary.
**Known HIV infection that is not well controlled.** Well controlled HIV infection is defined as meeting all of the following criteria: undetectable viral RNA load, CD4+ count ≥ 350 cells/µL, no history of opportunistic infection as defined by AIDS within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medication (i.e., during this period, no further changes are expected in the number or type of antiretroviral drug in the treatment regimen). If HIV infection meets the above criteria, monitoring of viral RNA and CD4+ count is recommended. 10. Has an open pulmonary tuberculosis infection (clinical evaluation may include clinical history, physical examination, and radiographic findings, or tuberculosis testing in accordance with local practice).
11. Has a history of clinically significant arrhythmias, cardiomyopathy of any etiology; symptomatic congestive heart failure (≥ grade 3 according to the New York Heart Association definition), or a history of myocardial infarction within the past 6 months.
12. Has a medical contraindication to platinum-based chemotherapy.
Previous/Concomitant Therapies
13. This condition does not apply in this version of the plan.
14. Has previously received any systemic therapy for advanced or mNSCLC.
Note: Prior adjuvant or adjuvant systemic therapy and/or definitive radiation or chemoradiotherapy for early resectable disease is permitted, provided that relapse or exacerbation occurs > 12 months after the end of treatment.
15. Has previously received any anti-TIGIT therapy, or any other anticancer therapy targeting immunomodulatory receptors or mechanisms of action.
16. Prior treatment with any anti-PD-1 or anti-PD-L1 medication.
17. Any treatment for cancer concurrent with chemotherapy, radiation therapy, immunotherapy, experimental therapy, or biological or hormonal therapy, other than the investigational therapy in this trial. Concomitant hormonal therapy for non-cancer-related conditions (such as insulin therapy for diabetes, HRT, gonadotropin-releasing hormone, and bisphosphonates) is acceptable.
18. Received minor, palliative radiation therapy within 2 weeks prior to the first dose of trial treatment, or major radiation therapy covering more than 30% of the bone marrow within 4 weeks prior. Note: Local treatment for a single lesion for palliative purposes is acceptable.
19. Underwent major surgery (excluding vascular access placement) or experienced major trauma within 4 weeks prior to the first dose of trial treatment, or is expected to undergo major surgery during the trial. Note: Local surgery for a single lesion for palliative purposes is acceptable.
20. Exclusion is made from the use of immunosuppressive drugs (currently or previously) within 14 days prior to the first dose of the experimental treatment. The following are exceptions to this condition (see Appendix I):
(a) Intranasal, inhaled, topical, or intra-articular injections of steroids (e.g., intra-articular injections).
(b) Single doses of steroids as a pre-operative treatment for allergic reactions (e.g., pre-CT scan), as a pre-operative treatment for chemotherapy, or for palliative purposes (e.g., pain control).
(c) Systemic corticosteroids not exceeding 10 mg prednisone or 2 mg dexamethasone daily, or equivalent physiological doses (excluding treatment for adverse events).
21. Exclusion is made from the use of herbal or natural products to treat or prevent any type of cancer that may interfere with the activity of the experimental treatment, see Appendix I.
22. Receive a live attenuated virus vaccine within 30 days prior to the first dose of the experimental treatment. Note: If a participant is enrolled in the trial, they should not receive the live vaccine during the treatment period and within 30 days after the last dose of the test treatment. See Appendix I for further details.
Previous/Concomitant Clinical Trial Experience
23. Participation in another clinical trial and having received the investigational treatment, investigational medical device, or treatment combination/control drug within the past 12 months (unless safety data were known prior to randomization), or concurrent enrollment in another clinical trial (unless the trial is observational [non-invasive] or the participant is in the follow-up period of an invasive trial).
24. The participant has a known allergy to any excipient of the investigational treatment or drug.
Other Exclusions
25. Participation in the planning and/or execution of this trial (applicable to AstraZeneca employees and/or trial center staff).
26. The trial administrator determines that the participant is unlikely to comply with the trial procedures, limitations, and requirements, and therefore the participant should not participate in the trial.
27. Previous enrollment in this trial. Note: Participants may be re-screened; see Section 5.4 for details.
28. Applicable only to women who are currently pregnant (with a confirmed positive pregnancy test), breastfeeding, or planning to become pregnant.
29. Female participants should avoid breastfeeding throughout the trial screening period and until 4 months after the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration).
1. In the opinion of the trial administrator, any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active bleeding disorders, persistent or active known infections; ILD (any grade), severe chronic gastrointestinal disease associated with diarrhea (e.g., active inflammatory bowel disease), active non-infectious skin disease requiring systemic treatment (including any grade of rash, urticaria, dermatitis, ulcers, or psoriasis), mental illness/social status, substance abuse, or major heart disease, which the trial administrator deems unsuitable for participation in the trial or will affect adherence to the trial protocol.
2. History of organ transplantation.
3. Having an active or previously documented autoimmune or inflammatory disease requiring long-term steroid or other immunosuppressive therapy.
4. History of other primary malignancies, excluding malignancies that have received curative treatment, have no known active disease for ≥ 2 years prior to the first dose of trial treatment, and have a very low potential risk of recurrence. Exceptions include fully excised non-melanoma skin cancer and in situ disease that has received curative treatment.
5. Presence of small cell and neuroendocrine histological components.
6. Persistent toxicity due to prior anticancer therapy (Common Adverse Event Evaluation Criteria (CTCAE) ≥ Grade 2), excluding alopecia. Participants with the following chronic, stable Grade 2 toxicities (defined as not worsening to > Grade 2 for at least 3 months prior to the first dose of trial treatment and managed with standard of care [SoC]) as determined by the trial administrator may be included, such as:
(a) Chemotherapy-induced neuropathy.
(b) Fatigue.
(c) Vitiligo.
(d) Endocrine disorders controlled by alternative hormone therapy.
(e) Participants may be included if the trial administrator believes that the participant's irreversible toxicity is not reasonably expected to worsen with trial treatment (e.g., hearing loss).
7. Spinal cord compression and/or leptomeningeal carcinoma.
8. Brain metastases, unless asymptomatic, stable, and not requiring steroids or antiepileptic drugs for at least 7 days prior to randomization. There must be at least a 2-week interval between the completion of local treatment (brain radiation therapy or surgery) and randomization. Participants must have recovered from acute toxicities of radiation therapy (e.g., signs of dizziness and increased intracranial pressure) or surgery prior to randomization.
9. Active primary immunodeficiency/active infectious disease:
• Known active hepatitis A.
• Acute hepatitis B infection (anti-HBc IgM positive) or chronic hepatitis B infection with HBV DNA ≥ 2000 IU/ml.
Participants with chronic hepatitis B infection and HBV DNA < 2000 IU/ml may be included, provided they receive antiviral prophylaxis and/or their HBV status is monitored, as shown in Figure 3.
• Active hepatitis C infection (positive anti-HCV antibody and detectable HCV RNA) or positive anti-HCV antibody and undetectable HCV RNA within 12 weeks of HCV treatment.
**Participants who are positive for anti-HCV antibodies and whose HCV RNA has been undetectable for at least 12 weeks due to successful treatment or spontaneous clearance of HCV infection are eligible to participate. These participants do not need to be tested for HCV RNA periodically during the study unless clinically necessary.
**Known HIV infection that is not well controlled.** Well controlled HIV infection is defined as meeting all of the following criteria: undetectable viral RNA load, CD4+ count ≥ 350 cells/µL, no history of opportunistic infection as defined by AIDS within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medication (i.e., during this period, no further changes are expected in the number or type of antiretroviral drug in the treatment regimen). If HIV infection meets the above criteria, monitoring of viral RNA and CD4+ count is recommended. 10. Has an open pulmonary tuberculosis infection (clinical evaluation may include clinical history, physical examination, and radiographic findings, or tuberculosis testing in accordance with local practice).
11. Has a history of clinically significant arrhythmias, cardiomyopathy of any etiology; symptomatic congestive heart failure (≥ grade 3 according to the New York Heart Association definition), or a history of myocardial infarction within the past 6 months.
12. Has a medical contraindication to platinum-based chemotherapy.
Previous/Concomitant Therapies
13. This condition does not apply in this version of the plan.
14. Has previously received any systemic therapy for advanced or mNSCLC.
Note: Prior adjuvant or adjuvant systemic therapy and/or definitive radiation or chemoradiotherapy for early resectable disease is permitted, provided that relapse or exacerbation occurs > 12 months after the end of treatment.
15. Has previously received any anti-TIGIT therapy, or any other anticancer therapy targeting immunomodulatory receptors or mechanisms of action.
16. Prior treatment with any anti-PD-1 or anti-PD-L1 medication.
17. Any treatment for cancer concurrent with chemotherapy, radiation therapy, immunotherapy, experimental therapy, or biological or hormonal therapy, other than the investigational therapy in this trial. Concomitant hormonal therapy for non-cancer-related conditions (such as insulin therapy for diabetes, HRT, gonadotropin-releasing hormone, and bisphosphonates) is acceptable.
18. Received minor, palliative radiation therapy within 2 weeks prior to the first dose of trial treatment, or major radiation therapy covering more than 30% of the bone marrow within 4 weeks prior. Note: Local treatment for a single lesion for palliative purposes is acceptable.
19. Underwent major surgery (excluding vascular access placement) or experienced major trauma within 4 weeks prior to the first dose of trial treatment, or is expected to undergo major surgery during the trial. Note: Local surgery for a single lesion for palliative purposes is acceptable.
20. Exclusion is made from the use of immunosuppressive drugs (currently or previously) within 14 days prior to the first dose of the experimental treatment. The following are exceptions to this condition (see Appendix I):
(a) Intranasal, inhaled, topical, or intra-articular injections of steroids (e.g., intra-articular injections).
(b) Single doses of steroids as a pre-operative treatment for allergic reactions (e.g., pre-CT scan), as a pre-operative treatment for chemotherapy, or for palliative purposes (e.g., pain control).
(c) Systemic corticosteroids not exceeding 10 mg prednisone or 2 mg dexamethasone daily, or equivalent physiological doses (excluding treatment for adverse events).
21. Exclusion is made from the use of herbal or natural products to treat or prevent any type of cancer that may interfere with the activity of the experimental treatment, see Appendix I.
22. Receive a live attenuated virus vaccine within 30 days prior to the first dose of the experimental treatment. Note: If a participant is enrolled in the trial, they should not receive the live vaccine during the treatment period and within 30 days after the last dose of the test treatment. See Appendix I for further details.
Previous/Concomitant Clinical Trial Experience
23. Participation in another clinical trial and having received the investigational treatment, investigational medical device, or treatment combination/control drug within the past 12 months (unless safety data were known prior to randomization), or concurrent enrollment in another clinical trial (unless the trial is observational [non-invasive] or the participant is in the follow-up period of an invasive trial).
24. The participant has a known allergy to any excipient of the investigational treatment or drug.
Other Exclusions
25. Participation in the planning and/or execution of this trial (applicable to AstraZeneca employees and/or trial center staff).
26. The trial administrator determines that the participant is unlikely to comply with the trial procedures, limitations, and requirements, and therefore the participant should not participate in the trial.
27. Previous enrollment in this trial. Note: Participants may be re-screened; see Section 5.4 for details.
28. Applicable only to women who are currently pregnant (with a confirmed positive pregnancy test), breastfeeding, or planning to become pregnant.
29. Female participants should avoid breastfeeding throughout the trial screening period and until 4 months after the last dose of blinded trial treatment and 6 months after the last dose of chemotherapy (unless local prescribing information requires a longer duration).
The Estimated Number of Participants
-
Taiwan
60 participants
-
Global
878 participants
