A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

  • STATUS
    Recruiting
  • End date
    Mar 15, 2024
  • participants needed
    636
  • sponsor
    Shanghai Henlius Biotech
Updated on 13 May 2022
cancer
measurable disease
avastin
lung cancer
pemetrexed
carboplatin
ROS1
EGFR
administration intravenous

Summary

This study involves a two-part design. Part 1 is designed to evaluate the safety and tolerability of the 4 drug (HLX10+HLX04+carboplatin+pemetrexed). Part 2 is a randomized, open-label study, which will evaluate the safety and efficacy of HLX10 in combination with carboplatin+pemetrexed with or without HLX04(biosimilar of avastin) compared with treatment with carboplatin+pemetrexed in 1st line Stage IIIB/IIIC or IV non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A (HLX10+HLX04+Carboplatin+Pemetrexed), Arm B (HLX10+HLX04 placebo+Carboplatin+Pemetrexed), or Arm C (HLX10 placebo + HLX04 placebo+Carboplatin+Pemetrexed).

Details
Condition Carcinoma, Non-Small-Cell Lung
Treatment carboplatin, Pemetrexed, HLX10, an engineered anti-PD-1 antibody, HLX04, a bevacizumab biosimilar
Clinical Study IdentifierNCT03952403
SponsorShanghai Henlius Biotech
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed, Stage IIIB/IIIC or IV non-squamous NSCLC
Participants with no EGFR, ALK and ROS1 mutation
Participants with no prior treatment for Stage IIIB/IIIC or IV non-squamous NSCLC
Measurable disease as defined by RECIST v1.1
Eastern Cooperative Oncology Group performance status 0 or 1
Adequate hematologic and end organ function

Exclusion Criteria

Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Active central nervous system metastases
Prior treatment with cluster of differentiation immune checkpoint blockade therapies or Bevacizumab
Has received a surgical operation within 4 weeks from the initial drug administration
Active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll
Currently having or have had interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis and severe impaired pulmonary function that may interfere with the detection and management of suspected drug-related pulmonary toxicity
Any active infection requiring systemic anti-infective therapy within 14 days prior to study drug administration
Uncontrollable active infection(s)
History of immunodeficiency, including HIV antibody positive
active hepatitis B; or hepatitis C virus infections
Has bleeding tendency
History of severe cardiovascular diseases
Known gastrointestinal diseases as follows, Gastrointestinal perforation, abdominal fistula or abdominal abscess within 6 months before signing the informed consent; History of poorly controlled or recurrent inflammatory bowel disease; Active peptic ulcers, or > moderate esophageal varices
Pregnant or breastfeeding female
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