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Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

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ClinicalTrials.gov Identifier: NCT03432598
Recruitment Status : Active, not recruiting
First Posted : February 14, 2018
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB A317 in combination with standard platinum-based chemotherapy in participants with advanced NSCLC or SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort, squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Participants with a mixed adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on the predominant histopathological profile. (e.g., participants with adenocarcinoma component accounting for > 50% will be allocated to non-squamous NSCLC cohort.). Participants with squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage and Cohort B dose-expansion Stage.

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 Design
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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 : April 2, 2018
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
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
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
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
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


Outcome Measures
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Primary Outcome Measures :
  1. The objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 2 years ]
    The proportion of participants who had confirmed complete response (CR) or partial response (PR) assessed by investigator per RECIST v1.1


Secondary Outcome Measures :
  1. The incidence and severity of adverse events (AEs) according to NCI-CTCAE Version 4.03 [ Time Frame: Up to 2 years ]
  2. 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 2 years ]
  3. 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 2 years ]
  4. Disease Control Rate (DCR) - defined as the proportion of participants who achieve CR, PR and SD using RECIST v1.1 [ Time Frame: Up to 2 years ]
  5. Pharmacokinetic evaluations of BGB-A317 in combination with chemotherapy: including but not limited to Ctrough [ Time Frame: Up to 2 years ]
  6. Anti-BGB-A317 antibody: immunogenic responses to BGB-A317 will be assessed to determine occurrence of anti-drug antibody. [ Time Frame: Up to 2 years ]
  7. The abnormality of laboratory tests according to NCI CTCAE Version 4.03 [ Time Frame: Up to 2 years ]

Eligibility Criteria
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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
Criteria

Key Inclusion Criteria:

  1. Male or female, aged 18-75 years on the day of signing informed consent.

  2. 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.

  3. 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.
  4. 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:

  1. 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.
  2. 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
  3. Prior therapies targeting PD-1, PD-L1 or PD-L2

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Jie Wang, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
More Information
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Publications:

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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: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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