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

• Status: Recruiting
• Trial end date: 2022-09-22
• Target enrollment: 0
• Participant gender: All

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+Carboplatin+Pemetrexed), or Arm C (Carboplatin+Pemetrexed).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech
• Treatments: Antibodies; Bevacizumab; Carboplatin; Immunoglobulins; Pemetrexed

Criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed, Stage IIIB/IIIC or IV non-squamous NSCLC

2. Participants with no EGFR, ALK and ROS1 mutation.

3. Participants with no prior treatment for Stage IIIB/IIIC or IV non-squamous NSCLC

4. Measurable disease as defined by RECIST v1.1

5. Eastern Cooperative Oncology Group performance status 0 or 1

6. Adequate hematologic and end organ function

Exclusion Criteria:

1. 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

2. Active central nervous system metastases

3. Prior treatment with cluster of differentiation immune checkpoint blockade therapies or Bevacizumab

4. Has received a surgical operation within 4 weeks from the initial drug administration

5. Active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll.

6. 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

7. Any active infection requiring systemic anti-infective therapy within 14 days prior to study drug administration

8. Uncontrollable active infection(s)

9. History of immunodeficiency, including HIV antibody positive

10. active hepatitis B; or hepatitis C virus infections

11. Has bleeding tendency

12. History of severe cardiovascular diseases

13. 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

14. Pregnant or breastfeeding female