Clinical Trials List
Protocol NumberD702BC00001
Active
2024-10-01 - 2029-09-30
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
TITLE PAGE 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 Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
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Trial Applicant
-
Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 邱立忠 無
- 吳教恩 無
- 柯皓文 無
- Chih-Hsi Kuo 無
- 林定佑 無
- Ping-Chih Hsu 無
- Chih-Hung Chen 無
- Chien-Ying Liu 無
- 黃宗楨 無
- Shih-Hong Li 無
- Chih-Liang Wang 無
- 枋岳甫 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Jen Yang 無
- 郭家佑 無
- Inn-Wen Chong 無
- Ying-Ming Tsai Tsai 無
- 莊政皓 無
- 李玫萱 無
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 Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
Objectives
To demonstrate the efficacy of
rilvegostomig plus chemotherapy relative to
pembrolizumab plus chemotherapy by
assessment of OS
Test Drug
injection
injection
injection
Active Ingredient
Rilvegostomig
Pembrolizumab
Pembrolizumab
Dosage Form
270
270
270
Dosage
750mg/15ml
100mg/4mL
100mg/4mL
Endpoints
OS is defined as the time from randomization until the date of
death due to any cause.
The analysis will include all randomized participants. All
deaths will be included regardless of whether the participant
withdraws from therapy or receives another anticancer
therapy.
The measure of interest is the HR of OS
death due to any cause.
The analysis will include all randomized participants. All
deaths will be included regardless of whether the participant
withdraws from therapy or receives another anticancer
therapy.
The measure of interest is the HR of OS
Inclution Criteria
1. Participants must be ≥18 years old at the time of signing the Independent Clinical Decision Form (ICF).
2. Histological or cytological evidence of squamous non-small cell lung cancer (NSCLC).
Note: Participants with a mixed adenosquamous morphology tumor deemed by the trial administrator to be treatable as squamous neoplasms are eligible.
3. Stage IV metastatic non-small cell lung cancer (mNSCLC) unsuitable for curative treatment (according to the American Joint Committee on Cancer Staging Manual, 8th edition).
4. As part of standard local practice, testing for any medically actionable driver oncogenes for locally approved first-line (1L) targeted therapy, with no recorded tumor gene mutations.
Note: If not part of standard local practice, gene mutation testing is not required.
5. WHO/East Coast Cancer Clinical Research Consortium (WHO/ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the screening baseline and before randomization.
6. The minimum life expectancy is 12 weeks.
7. Acceptable tumor specimens must be provided, according to the definitions in the Pathology Manual and Laboratory Manual, to confirm tumor PD-L1 expression (TC) ≥ 1% using the VENTANA PD-L1 (SP263) analysis kit at the central laboratory designated by the trial client prior to randomization. Participants with undetermined PD-L1 status or TC < 1% are ineligible for the trial.
Note: If PD-L1 status has already been determined using the VENTANA PD-L1 (SP263) analysis kit as part of screening in another AstraZeneca trial specifying the same central laboratory, the results may be used if the specimens are eligible.
8. At the baseline period, at least one previously un-radiated lesion must be a target lesion (TL) meeting the RECIST 1.1 criteria for assessment of response to solid tumors (RECIST 1.1), and its longest diameter at the baseline period must be ≥ 10 mm (excluding lymph nodes, whose short axis must be ≥ 15 mm) and accurately repeatable, as accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI).
9. Participants must have adequate organ and bone marrow function as defined in the table below.
10. Participants must weigh at least 30 kg.
11. The method of contraception used by the participant must be consistent with the contraceptive methods used by clinical trial participants under local regulations; more details are available below.
12. Female participants of fertility:
(a) Pregnancy tests must be negative at screening and prior to day 1 of each trial treatment.
(b) If having sexual intercourse with an unsterilized male partner, at least one highly effective method of contraception must be used 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 period).
(c) 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 period), the unsterilized male partner of a fertile female participant 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 period), breastfeeding and donating or collecting eggs for personal use are prohibited.
13. Unsterilized male participants who have sexual relations with fertile female partners:
(a) From 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 period), unsterilized male participants who do not abstain and wish to have sexual relations 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 (fertile) female partner of the male participant must also use at least one highly effective method of contraception throughout the trial participation period, 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 period). (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 period), male participants should avoid impregnating others or donating sperm.
14. Able to provide signed participant consent forms, including a commitment to comply with the participant consent forms and the requirements and restrictions listed in this trial protocol.
15. Provide signed and dated written participant consent forms for selective genetic research information before collecting specimens to support the genomics project. (Not applicable to Taiwan)
16. All races, sexes, and ethnicities are eligible to participate in this trial.
2. Histological or cytological evidence of squamous non-small cell lung cancer (NSCLC).
Note: Participants with a mixed adenosquamous morphology tumor deemed by the trial administrator to be treatable as squamous neoplasms are eligible.
3. Stage IV metastatic non-small cell lung cancer (mNSCLC) unsuitable for curative treatment (according to the American Joint Committee on Cancer Staging Manual, 8th edition).
4. As part of standard local practice, testing for any medically actionable driver oncogenes for locally approved first-line (1L) targeted therapy, with no recorded tumor gene mutations.
Note: If not part of standard local practice, gene mutation testing is not required.
5. WHO/East Coast Cancer Clinical Research Consortium (WHO/ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the screening baseline and before randomization.
6. The minimum life expectancy is 12 weeks.
7. Acceptable tumor specimens must be provided, according to the definitions in the Pathology Manual and Laboratory Manual, to confirm tumor PD-L1 expression (TC) ≥ 1% using the VENTANA PD-L1 (SP263) analysis kit at the central laboratory designated by the trial client prior to randomization. Participants with undetermined PD-L1 status or TC < 1% are ineligible for the trial.
Note: If PD-L1 status has already been determined using the VENTANA PD-L1 (SP263) analysis kit as part of screening in another AstraZeneca trial specifying the same central laboratory, the results may be used if the specimens are eligible.
8. At the baseline period, at least one previously un-radiated lesion must be a target lesion (TL) meeting the RECIST 1.1 criteria for assessment of response to solid tumors (RECIST 1.1), and its longest diameter at the baseline period must be ≥ 10 mm (excluding lymph nodes, whose short axis must be ≥ 15 mm) and accurately repeatable, as accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI).
9. Participants must have adequate organ and bone marrow function as defined in the table below.
10. Participants must weigh at least 30 kg.
11. The method of contraception used by the participant must be consistent with the contraceptive methods used by clinical trial participants under local regulations; more details are available below.
12. Female participants of fertility:
(a) Pregnancy tests must be negative at screening and prior to day 1 of each trial treatment.
(b) If having sexual intercourse with an unsterilized male partner, at least one highly effective method of contraception must be used 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 period).
(c) 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 period), the unsterilized male partner of a fertile female participant 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 period), breastfeeding and donating or collecting eggs for personal use are prohibited.
13. Unsterilized male participants who have sexual relations with fertile female partners:
(a) From 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 period), unsterilized male participants who do not abstain and wish to have sexual relations 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 (fertile) female partner of the male participant must also use at least one highly effective method of contraception throughout the trial participation period, 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 period). (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 period), male participants should avoid impregnating others or donating sperm.
14. Able to provide signed participant consent forms, including a commitment to comply with the participant consent forms and the requirements and restrictions listed in this trial protocol.
15. Provide signed and dated written participant consent forms for selective genetic research information before collecting specimens to support the genomics project. (Not applicable to Taiwan)
16. All races, sexes, and ethnicities are eligible to participate in this trial.
Exclusion Criteria
1. In the investigator's opinion, any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active bleeding disorders, persistent or active known infections; interstitial lung disease (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 investigator deems unsuitable for participation in the trial or will affect adherence to the trial protocol.
2. History of organ transplantation.
3. Known active or prior 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. Patients with small cell and neuroendocrine histological components.
6. Persistent toxicity (Common Adverse Event Evaluation Criteria (CTCAE) ≥ Grade 2) caused by prior anticancer therapy, excluding alopecia. Subject to the trial administrator's assessment, participants may be included if they experience any of the following chronic, stable Grade 2 toxicities associated with prior anticancer therapy (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]), such as:
(a) Chemotherapy-induced neuropathy.
(b) Fatigue.
(c) Vitiligo.
(d) Endocrine disorders controlled by alternative hormone therapy.
(e) If the trial administrator believes that irreversible toxicity occurring in a participant will not be exacerbated by the trial treatment within a reasonably expected range (e.g., hearing loss), they may be included.
7. Spinal cord compression and/or leptomeningeal metastasis.
8. Brain metastases, unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. There must be at least a 2-week interval between the completion of local therapy (brain radiation therapy or surgery) and randomization. Participants must have recovered from acute toxicities of radiation therapy (e.g., dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
9. Active primary immunodeficiency/active infectious disease:
• Known active hepatitis A infection.
• Acute hepatitis B infection (positive anti-HBc IgM), or chronic hepatitis B infection with hepatitis B virus DNA (HBV DNA) ≥ 2000 IU/ml.
• Participants with chronic hepatitis B infection and HBV DNA < 2000 IU/ml may be included if they are receiving antiviral prophylaxis and/or undergoing HBV status monitoring.
• Active hepatitis C infection (positive anti-HCV antibody and detectable HCV RNA), or positive anti-HCV antibody and undetectable HCV RNA for less than 12 weeks following HCV treatment.
Participants who are positive for anti-HCV antibodies and whose HCV RNA has been undetectable for at least 12 weeks (whether 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 trial 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 that could define AIDS within the past 12 months, and stability for at least 4 weeks on the same anti-HIV medication (i.e., no further changes in the amount or type of antiretroviral medication expected during this period). If HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.
10. Active pulmonary tuberculosis infection (clinical evaluation may include clinical history, physical examination, and radiological findings, or tuberculosis testing in accordance with local practice).
11. History of clinically significant arrhythmias, cardiomyopathy of any etiology; symptomatic congestive heart failure (defined as New York Heart Association grade ≥ 3), or a history of myocardial infarction within the past 6 months.
12. Medical contraindications to platinum-based chemotherapy.
13. Use of any medication known to be associated with the treatment of multiform ventricular arrhythmias. (This criterion does not apply to the current program.)
14. Previous treatment with any systemic therapy for advanced or metastatic non-small cell lung cancer.
Note: Prior treatment with early-stage disease, including pre- or adjuvant systemic therapy and/or definitive radiation or chemoradiotherapy, is permitted, provided that disease recurrence or exacerbation occurs > 12 months after the end of treatment.
15. Prior treatment with any anti-TIGIT therapy or any other anticancer therapy targeting immunomodulatory receptors or mechanisms.
16. Prior treatment with any anti-PD-1 or anti-PD-L1 drugs.
17. Any treatment for cancer, in combination with chemotherapy, radiation therapy, immunotherapy, experimental therapy, or biological or hormonal therapy, other than the therapy investigated in this trial. Hormonal therapies used to treat non-cancer-related conditions are permitted (e.g., insulin therapy for diabetes, hormone replacement therapy [HRT], gonadotropin-releasing hormone, and bisphosphonates).
18. Painless radiation therapy includes limited-area radiation therapy within the first 2 weeks of the first dose of trial treatment, wide-area radiation therapy within the first 4 weeks, or irradiation of more than 30% of the bone marrow area.
Note: Local treatment for palliative purposes to isolated lesions is acceptable.
19. Having undergone major surgery (excluding vascular access placement) or experienced major trauma within 4 weeks prior to the first dose of trial treatment, or anticipating the need for major surgery during the trial.
Note: Local surgery for palliative purposes to isolated lesions is acceptable.
20. Current or prior use of immunosuppressive drugs within 14 days prior to the first dose of trial treatment is excluded. The following are exceptions to this condition:
(a) Intranasal, inhaled, topical, or local steroid injections (such as intra-articular injections).
(b) Steroids used preoperatively for allergic reactions (e.g., preoperative administration of CT scans), preoperative administration of chemotherapy, or as a single dose for palliative purposes (e.g., pain control).
(c) Physiological doses of systemic corticosteroids not exceeding 10 mg of prednisone or 2 mg of dexamethasone daily, or other equivalents (excluding treatment for adverse events).
21. Exclusion is made if herbal or natural products that may interfere with the activity of the investigational treatment are used to treat or prevent any type of cancer.
22. Received an active attenuated vaccine within 30 days prior to the first dose of the investigational treatment.
Note: If a participant is enrolled in the trial, they should not receive an active vaccine during the investigational treatment and within 30 days after the last dose of the investigational treatment.
23. Participation in another clinical trial where the participant received the investigational treatment or investigational medical device, or was concurrently/with a 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.
25. Participation in the planning and/or execution of this trial (applicable to AstraZeneca employees and/or trial center staff).
26. Participants should not participate in the trial if the trial administrator determines that it is unlikely that they will comply with the trial procedures, limitations, and requirements.
27. Previously enrolled in this trial. Note: Participants may be rescreened once.
28. Applicable only to women: Currently pregnant (confirmed pregnancy test result) or breastfeeding, or planning to become pregnant.
29. Female participants should avoid breastfeeding throughout the trial from screening, and until 4 months after the last blinded trial treatment and 6 months after the last chemotherapy dose (unless local prescribing information requires a longer period).
2. History of organ transplantation.
3. Known active or prior 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. Patients with small cell and neuroendocrine histological components.
6. Persistent toxicity (Common Adverse Event Evaluation Criteria (CTCAE) ≥ Grade 2) caused by prior anticancer therapy, excluding alopecia. Subject to the trial administrator's assessment, participants may be included if they experience any of the following chronic, stable Grade 2 toxicities associated with prior anticancer therapy (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]), such as:
(a) Chemotherapy-induced neuropathy.
(b) Fatigue.
(c) Vitiligo.
(d) Endocrine disorders controlled by alternative hormone therapy.
(e) If the trial administrator believes that irreversible toxicity occurring in a participant will not be exacerbated by the trial treatment within a reasonably expected range (e.g., hearing loss), they may be included.
7. Spinal cord compression and/or leptomeningeal metastasis.
8. Brain metastases, unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. There must be at least a 2-week interval between the completion of local therapy (brain radiation therapy or surgery) and randomization. Participants must have recovered from acute toxicities of radiation therapy (e.g., dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
9. Active primary immunodeficiency/active infectious disease:
• Known active hepatitis A infection.
• Acute hepatitis B infection (positive anti-HBc IgM), or chronic hepatitis B infection with hepatitis B virus DNA (HBV DNA) ≥ 2000 IU/ml.
• Participants with chronic hepatitis B infection and HBV DNA < 2000 IU/ml may be included if they are receiving antiviral prophylaxis and/or undergoing HBV status monitoring.
• Active hepatitis C infection (positive anti-HCV antibody and detectable HCV RNA), or positive anti-HCV antibody and undetectable HCV RNA for less than 12 weeks following HCV treatment.
Participants who are positive for anti-HCV antibodies and whose HCV RNA has been undetectable for at least 12 weeks (whether 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 trial 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 that could define AIDS within the past 12 months, and stability for at least 4 weeks on the same anti-HIV medication (i.e., no further changes in the amount or type of antiretroviral medication expected during this period). If HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.
10. Active pulmonary tuberculosis infection (clinical evaluation may include clinical history, physical examination, and radiological findings, or tuberculosis testing in accordance with local practice).
11. History of clinically significant arrhythmias, cardiomyopathy of any etiology; symptomatic congestive heart failure (defined as New York Heart Association grade ≥ 3), or a history of myocardial infarction within the past 6 months.
12. Medical contraindications to platinum-based chemotherapy.
13. Use of any medication known to be associated with the treatment of multiform ventricular arrhythmias. (This criterion does not apply to the current program.)
14. Previous treatment with any systemic therapy for advanced or metastatic non-small cell lung cancer.
Note: Prior treatment with early-stage disease, including pre- or adjuvant systemic therapy and/or definitive radiation or chemoradiotherapy, is permitted, provided that disease recurrence or exacerbation occurs > 12 months after the end of treatment.
15. Prior treatment with any anti-TIGIT therapy or any other anticancer therapy targeting immunomodulatory receptors or mechanisms.
16. Prior treatment with any anti-PD-1 or anti-PD-L1 drugs.
17. Any treatment for cancer, in combination with chemotherapy, radiation therapy, immunotherapy, experimental therapy, or biological or hormonal therapy, other than the therapy investigated in this trial. Hormonal therapies used to treat non-cancer-related conditions are permitted (e.g., insulin therapy for diabetes, hormone replacement therapy [HRT], gonadotropin-releasing hormone, and bisphosphonates).
18. Painless radiation therapy includes limited-area radiation therapy within the first 2 weeks of the first dose of trial treatment, wide-area radiation therapy within the first 4 weeks, or irradiation of more than 30% of the bone marrow area.
Note: Local treatment for palliative purposes to isolated lesions is acceptable.
19. Having undergone major surgery (excluding vascular access placement) or experienced major trauma within 4 weeks prior to the first dose of trial treatment, or anticipating the need for major surgery during the trial.
Note: Local surgery for palliative purposes to isolated lesions is acceptable.
20. Current or prior use of immunosuppressive drugs within 14 days prior to the first dose of trial treatment is excluded. The following are exceptions to this condition:
(a) Intranasal, inhaled, topical, or local steroid injections (such as intra-articular injections).
(b) Steroids used preoperatively for allergic reactions (e.g., preoperative administration of CT scans), preoperative administration of chemotherapy, or as a single dose for palliative purposes (e.g., pain control).
(c) Physiological doses of systemic corticosteroids not exceeding 10 mg of prednisone or 2 mg of dexamethasone daily, or other equivalents (excluding treatment for adverse events).
21. Exclusion is made if herbal or natural products that may interfere with the activity of the investigational treatment are used to treat or prevent any type of cancer.
22. Received an active attenuated vaccine within 30 days prior to the first dose of the investigational treatment.
Note: If a participant is enrolled in the trial, they should not receive an active vaccine during the investigational treatment and within 30 days after the last dose of the investigational treatment.
23. Participation in another clinical trial where the participant received the investigational treatment or investigational medical device, or was concurrently/with a 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.
25. Participation in the planning and/or execution of this trial (applicable to AstraZeneca employees and/or trial center staff).
26. Participants should not participate in the trial if the trial administrator determines that it is unlikely that they will comply with the trial procedures, limitations, and requirements.
27. Previously enrolled in this trial. Note: Participants may be rescreened once.
28. Applicable only to women: Currently pregnant (confirmed pregnancy test result) or breastfeeding, or planning to become pregnant.
29. Female participants should avoid breastfeeding throughout the trial from screening, and until 4 months after the last blinded trial treatment and 6 months after the last chemotherapy dose (unless local prescribing information requires a longer period).
The Estimated Number of Participants
-
Taiwan
24 participants
-
Global
880 participants
