Clinical Trials List
Protocol NumberBO42592
Active
2020-12-01 - 2027-12-31
Phase II/III
Recruiting1
Terminated2
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 II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TIRAGOLUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN VERSUS PEMBROLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED NON-SQUAMOUS NON SMALL CELL LUNG CANCER
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chi-Lu Chiang Division of Thoracic Medicine
- Chia-I Shen Division of Thoracic Medicine
- Heng-Sheng Chao Division of Thoracic Medicine
- Hsu-ching Huang Division of Thoracic Medicine
- 趙恒勝 Division of Thoracic Medicine
- Yung-Hung Luo Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 葉金水 Division of Thoracic Medicine
- 張竣期 Division of Thoracic Medicine
- 黃國揚 Division of Thoracic Medicine
- 林慶雄 Division of Thoracic Medicine
- 林明泰 Division of Thoracic Medicine
- 詹博強 Division of Thoracic Medicine
- 施穎銘 Division of Thoracic Medicine
- 蔡偉宏 Division of Thoracic Medicine
- 陳正雄 Division of Thoracic Medicine
- 紀炳銓 Division of Thoracic Medicine
- 林俊維 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 陳鴻仁 Division of Thoracic Medicine
- Chen Chia-Hung Division of Thoracic Medicine
- 廖偉志 Division of Thoracic Medicine
- Chih-Yen Tu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
NON-SMALL CELL LUNG CANCER
Objectives
This is a randomized, Phase II, global, multicenter, double-blind study designed to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin in patients with previously untreated, locally advanced unresectable or metastatic non-squamous non small cell lung cancer (NSCLC).
Test Drug
TiragolumabAtezolizumab
Active Ingredient
Tiragolumab
Atezolizumab
Atezolizumab
Dosage Form
injection
Dosage
600mg/10ml
1200mg/20ml
1200mg/20ml
Endpoints
Efficacy Objectives
Primary Efficacy Objective
The primary efficacy objective for this study is to evaluate the efficacy of tiragolumab in
combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared
with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin
(Arm B) on the basis of the following endpoints:
Confirmed objective response rate (ORR), defined as the proportion of patients with a
confirmed objective response (i.e. complete response [CR] or partial response [PR], on two
consecutive occasions 4 weeks apart), as determined by the investigator according to
Response Evaluation Criteria in Solid Tumors, Versions 1.1 (RECIST v1.1)
Progression-free survival (PFS), defined as the time from randomization to the first
occurrence of disease progression or death from any cause (
Primary Efficacy Objective
The primary efficacy objective for this study is to evaluate the efficacy of tiragolumab in
combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared
with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin
(Arm B) on the basis of the following endpoints:
Confirmed objective response rate (ORR), defined as the proportion of patients with a
confirmed objective response (i.e. complete response [CR] or partial response [PR], on two
consecutive occasions 4 weeks apart), as determined by the investigator according to
Response Evaluation Criteria in Solid Tumors, Versions 1.1 (RECIST v1.1)
Progression-free survival (PFS), defined as the time from randomization to the first
occurrence of disease progression or death from any cause (
Inclution Criteria
Patients must meet the following criteria for study entry:
Signed Informed Consent Form
Age≧18 years at time of signing Informed Consent Form
Ability to comply with the study protocol, in the investigator’s judgement
ECOG Performance Status of 0 or 1
Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC
Patients with tumors of mixed NSCLC histology must be classified as non-squamous on the basis of the major histological component.
Patients with mixed NSCLC and small cell lung cancer are not eligible for the study.
No prior systemic treatment for metastatic non-squamous NSCLC
Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 12 months from randomization since
the last dose of chemotherapy and/or radiotherapy.
Known tumor PD-L1 status through use of a local health authority-approved assay (SP263 [preferred], or 22C3 only if SP263 is not available) or by central laboratory assay (investigational VENTANA [SP263] CDx Assay) if an approved local test is not available
Confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded blocks (preferred) or at least 1520 unstained serial slides, along with an associated pathology report. If central testing for EGFR mutations and/or ALK translocations are required, an additional 5 unstained slides must be provided.
Tumor tissue should be of good quality based on total and viable tumor content (i.e., a minimum number of 100 viable tumor cells with preserved cellular context and tissue architecture). Acceptable samples include samples from resections, core-needle biopsies for deep tumor tissue (with a minimum of three cores for freshly collected biopsies) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions, or endobronchial ultrasound core needle biopsy.
Endobronchial ultrasound-transbronchial needle aspiration, which is sometimes referred to as a fine-needle aspiration, is acceptable (particularly if a larger gauge needle is used) provided tissue is of good quality as described above (i.e., a minimum
number of 100 viable tumor cells with preserved cellular context and tissue architecture). For needle aspirations, an 18 gauge or larger needle is recommended.
Fine-needle aspirations that do not preserve tissue architecture and yield cell suspension and/or cell smears, brushings, cell pellets from pleural effusions, and lavage samples are not acceptable.
Tumor tissue from bone metastases is not evaluable for tumor PD-L1 expression by IHC and is therefore not acceptable.
If archival tissue is either insufficient or unavailable, the patient may undergo a biopsy at screening if the biopsy site is safely accessible. If a biopsy cannot be provided, the patient may still be eligible upon discussion with the Medical Monitor if ≧10 unstained,serial slides can be provided.
Measurable disease, as defined by RECIST v1.1
Previously irradiated lesions can only be considered measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of measurable disease.
Life expectancy≧12 weeks
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment (Day 1 of Cycle 1):
– ANC ≧1.5×10^9/L (≧1500/L) without granulocyte colony-stimulating factor support
– Lymphocyte count≧0.5≧10^9/L(≧500/μL)
– Platelet count＞= 100 x 109/L (＞= 100,000/μL) without transfusion
Signed Informed Consent Form
Age≧18 years at time of signing Informed Consent Form
Ability to comply with the study protocol, in the investigator’s judgement
ECOG Performance Status of 0 or 1
Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC
Patients with tumors of mixed NSCLC histology must be classified as non-squamous on the basis of the major histological component.
Patients with mixed NSCLC and small cell lung cancer are not eligible for the study.
No prior systemic treatment for metastatic non-squamous NSCLC
Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 12 months from randomization since
the last dose of chemotherapy and/or radiotherapy.
Known tumor PD-L1 status through use of a local health authority-approved assay (SP263 [preferred], or 22C3 only if SP263 is not available) or by central laboratory assay (investigational VENTANA [SP263] CDx Assay) if an approved local test is not available
Confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded blocks (preferred) or at least 1520 unstained serial slides, along with an associated pathology report. If central testing for EGFR mutations and/or ALK translocations are required, an additional 5 unstained slides must be provided.
Tumor tissue should be of good quality based on total and viable tumor content (i.e., a minimum number of 100 viable tumor cells with preserved cellular context and tissue architecture). Acceptable samples include samples from resections, core-needle biopsies for deep tumor tissue (with a minimum of three cores for freshly collected biopsies) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions, or endobronchial ultrasound core needle biopsy.
Endobronchial ultrasound-transbronchial needle aspiration, which is sometimes referred to as a fine-needle aspiration, is acceptable (particularly if a larger gauge needle is used) provided tissue is of good quality as described above (i.e., a minimum
number of 100 viable tumor cells with preserved cellular context and tissue architecture). For needle aspirations, an 18 gauge or larger needle is recommended.
Fine-needle aspirations that do not preserve tissue architecture and yield cell suspension and/or cell smears, brushings, cell pellets from pleural effusions, and lavage samples are not acceptable.
Tumor tissue from bone metastases is not evaluable for tumor PD-L1 expression by IHC and is therefore not acceptable.
If archival tissue is either insufficient or unavailable, the patient may undergo a biopsy at screening if the biopsy site is safely accessible. If a biopsy cannot be provided, the patient may still be eligible upon discussion with the Medical Monitor if ≧10 unstained,serial slides can be provided.
Measurable disease, as defined by RECIST v1.1
Previously irradiated lesions can only be considered measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of measurable disease.
Life expectancy≧12 weeks
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment (Day 1 of Cycle 1):
– ANC ≧1.5×10^9/L (≧1500/L) without granulocyte colony-stimulating factor support
– Lymphocyte count≧0.5≧10^9/L(≧500/μL)
– Platelet count＞= 100 x 109/L (＞= 100,000/μL) without transfusion
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:
NSCLC known to have a mutation in the EGFR gene or an ALK fusion oncogene are excluded from the study.
Patients with non-squamous NSCLC who have an unknown EGFR or ALK status will be required to be tested at pre-screening or screening.
EGFR and/or ALK status may be assessed locally or at a central laboratory.
– EGFR status assessed locally must be performed on tissue or cytology using a validated health authority-approved test that detects mutations in exons 18-21.
– If samples are submitted for central EGFR and/or ALK testing, additional slides must be provided.
Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:
– Measurable disease, per RECIST v1.1, must be present outside the CNS.
– The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
– The patient has not undergone stereotactic radiotherapy within 7 days prior to randomization, whole-brain radiotherapy within 14 days prior to randomization, or neurosurgical resection within 28 days prior to randomization.
– The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.
– Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).
– There is no evidence of interim progression between completion of CNS-directed therapy and randomization.
Asymptomatic patients with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy or surgery, with no need to repeat the
screening brain scan.
Spinal cord compression not definitively treated with surgery and/or radiation or previously
diagnosed and treated spinal cord compression without evidence that disease has been
clinically stable for＞= 2 weeks prior to randomization.
History of leptomeningeal disease
Uncontrolled tumor-related pain
Patients requiring pain medication must have adequate pain control.
Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to randomization.
Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
NSCLC known to have a mutation in the EGFR gene or an ALK fusion oncogene are excluded from the study.
Patients with non-squamous NSCLC who have an unknown EGFR or ALK status will be required to be tested at pre-screening or screening.
EGFR and/or ALK status may be assessed locally or at a central laboratory.
– EGFR status assessed locally must be performed on tissue or cytology using a validated health authority-approved test that detects mutations in exons 18-21.
– If samples are submitted for central EGFR and/or ALK testing, additional slides must be provided.
Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:
– Measurable disease, per RECIST v1.1, must be present outside the CNS.
– The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
– The patient has not undergone stereotactic radiotherapy within 7 days prior to randomization, whole-brain radiotherapy within 14 days prior to randomization, or neurosurgical resection within 28 days prior to randomization.
– The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.
– Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).
– There is no evidence of interim progression between completion of CNS-directed therapy and randomization.
Asymptomatic patients with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy or surgery, with no need to repeat the
screening brain scan.
Spinal cord compression not definitively treated with surgery and/or radiation or previously
diagnosed and treated spinal cord compression without evidence that disease has been
clinically stable for＞= 2 weeks prior to randomization.
History of leptomeningeal disease
Uncontrolled tumor-related pain
Patients requiring pain medication must have adequate pain control.
Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to randomization.
Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
540 participants
