Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer
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| ClinicalTrials.gov Identifier: NCT03432598 |
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Recruitment Status :
Completed
First Posted : February 14, 2018
Last Update Posted : June 7, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Locally Advanced Lung Cancer; Metastatic Lung Cancer | Drug: Tislelizumab Drug: Paclitaxel Drug: Gemcitabine Drug: Etoposide Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 54 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Open-Label, Multi-Cohort Study to Investigate the Preliminary Antitumor Activity, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With Chemotherapy as First-Line Treatment in Chinese Subjects With Locally Advanced or Metastatic Lung Cancer |
| Actual Study Start Date : | August 24, 2017 |
| Actual Primary Completion Date : | February 25, 2019 |
| Actual Study Completion Date : | December 21, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Non-squamous NSCLC
Day 1 of each 21-day (3 weeks) cycle: Tislelizumab + pemetrexed + cisplatin 75 mg/m²/day IV (or carboplatin AUC 5). Pemetrexed plus cisplatin (or carboplatin) should be given for up to 4 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate. Pemetrexed maintenance after completion of doublet chemotherapy is permitted. |
Drug: Tislelizumab
Administered 200 mg intravenously (IV) as specified in the treatment arm
Other Name: BGB-A317 Drug: Pemetrexed Administered 500 mg/m² IV as specified in the treatment arm Drug: Cisplatin Administered 75 mg/m²/day IV as specified in the treatment arm Drug: Carboplatin Administered AUC 5 as specified in the treatment arm |
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Experimental: Squamous NSCLC Cohort A
Tislelizumab every 3 weeks (Q3W) + paclitaxel + cisplatin (or carboplatin), Q3W. Paclitaxel plus cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate. |
Drug: Tislelizumab
Administered 200 mg intravenously (IV) as specified in the treatment arm
Other Name: BGB-A317 Drug: Paclitaxel Administered 175 mg/m² IV as specified in the treatment arm Drug: Cisplatin Administered 75 mg/m²/day IV as specified in the treatment arm Drug: Carboplatin Administered AUC 5 as specified in the treatment arm |
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Experimental: Squamous NSCLC Cohort B
Tislelizumab Q3W on Day 1 + gemcitabine on Day 1 and Day 8 + cisplatin IV (or carboplatin) on Day 1. Gemcitabine plus cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate. |
Drug: Tislelizumab
Administered 200 mg intravenously (IV) as specified in the treatment arm
Other Name: BGB-A317 Drug: Gemcitabine Administered 1250 mg/m² IV as specified in the treatment arm Drug: Cisplatin Administered 75 mg/m²/day IV as specified in the treatment arm Drug: Carboplatin Administered AUC 5 as specified in the treatment arm |
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Experimental: SCLC
Tislelizumab Q3W on Day 1, etoposide on Days 1, 2, and 3 + cisplatin (or carboplatin) on Day 1. Etoposide and cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate. |
Drug: Etoposide
Administered 100 mg/m2 IV as specified in the treatment arm Drug: Cisplatin Administered 75 mg/m²/day IV as specified in the treatment arm Drug: Carboplatin Administered AUC 5 as specified in the treatment arm |
- The objective response rate (ORR) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 4 years ]
- The incidence and severity of adverse events (AEs) according to NCI-CTCAE Version 4.03 [ Time Frame: Up to 4 years ]
- Duration of Response (DoR) - defined as the time from the first determination of a confirmed objective response according to RECIST v1.1 until the first documentation of progression or death, whichever comes first [ Time Frame: Up to 4 years ]
- Progression-Free Survival (PFS) - defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression using RECIST v1.1 or death, whichever occurs first [ Time Frame: Up to 4 years ]
- Disease Control Rate (DCR) - defined as the proportion of participants who achieve CR, PR and SD using RECIST v1.1 [ Time Frame: Up to 4 years ]
- Pharmacokinetic evaluations of BGB-A317 in combination with chemotherapy: including but not limited to Ctrough [ Time Frame: Up to 4 years ]
- Anti-BGB-A317 antibody: immunogenic responses to BGB-A317 will be assessed to determine occurrence of anti-drug antibody. [ Time Frame: Up to 4 years ]
- The abnormality of laboratory tests according to NCI CTCAE Version 4.03 [ Time Frame: Up to 4 years ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Male or female, aged 18-75 years on the day of signing informed consent.
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Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, squamous NSCLC, or extensive-stage SCLC.
Note: Participants with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors.
- Have had no prior systemic therapy for advanced or metastatic disease. Prior neoadjuvant/adjuvant therapy or chemoradiation therapy with curative intent should have been completed at least 6 months prior to documentation of recurrence of disease.
- Participants must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded [FFPE] blocks or at least 10 unstained FFPE slides) with an associated pathological report.
Key Exclusion Criteria:
- Participants with a sensitizing mutation in EGFR gene or an ALK fusion oncogene (specifically for participants with non- squamous NSCLC). Participants with unknown mutation/fusion status of EGFR and/or ALK must take the respective test at the investigational sites (or other designated sites) prior to enrolment.
- Prior malignancy active within the previous 2 years exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
- Prior therapies targeting PD-1, PD-L1 or PD-L2
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432598
| China, Beijing | |
| Chinese Academy of Medical Sciences Tumor Hospital | |
| Beijing, Beijing, China, 100021 | |
| Beijing Cancer Hospital | |
| Beijing, Beijing, China, 100142 | |
| Beijing Chest Hospital | |
| Beijing, Beijing, China, 133500 | |
| China, Henan | |
| Henan Cancer Hospital | |
| Zhengzhou, Henan, China, 450008 | |
| China, Jiangsu | |
| Jaingsu People's Hospital | |
| Nanjing, Jiangsu, China, 210029 | |
| China, Jilin | |
| Jilin University First Hospital | |
| Changchun, Jilin, China, 130021 | |
| Jilin Cancer Hospital | |
| Changchun, Jilin, China, 132000 | |
| Principal Investigator: | Jie Wang, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Responsible Party: | BeiGene |
| ClinicalTrials.gov Identifier: | NCT03432598 |
| Other Study ID Numbers: |
BGB-A317-206 CTR20170361 ( Registry Identifier: Center for drug evaluation, CFDA ) |
| First Posted: | February 14, 2018 Key Record Dates |
| Last Update Posted: | June 7, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Paclitaxel Etoposide Carboplatin Pemetrexed Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Topoisomerase II Inhibitors Topoisomerase Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |