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Completed

NCT Number: NCT03432598

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Treatment and study plan

Tislelizumab

Drug

Administered 200 mg intravenously (IV) as specified in the treatment arm

Other names: BGB-A317

paclitaxel

Drug

Administered 175 mg/m² IV as specified in the treatment arm

Gemcitabine

Drug

Administered 1250 mg/m² IV as specified in the treatment arm

etoposide

Drug

Administered 100 mg/m2 IV as specified in the treatment arm

Pemetrexed

Drug

Administered 500 mg/m² IV as specified in the treatment arm

Cisplatin

Drug

Administered 75 mg/m²/day IV as specified in the treatment arm

carboplatin

Drug

Administered AUC 5 as specified in the treatment arm

Primary outcomes

  1. 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

Secondary outcomes

  1. The incidence and severity of adverse events (AEs) according to NCI-CTCAE Version 4.03

    Time frame: Up to 4 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 4 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 4 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 4 years

  5. Pharmacokinetic evaluations of BGB-A317 in combination with chemotherapy: including but not limited to Ctrough

    Time frame: Up to 4 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 4 years

  7. The abnormality of laboratory tests according to NCI CTCAE Version 4.03

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Feb 14, 2018
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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