AgingResearch.NewsJoin free

Phase 2/3Not yet recruiting

A Study to Learn the Safety and Efficacy of HLX37 in Combination With Chemotherapy for First-line Treatment in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Randomized, Double-Blind, Multicenter, Phase II/III Study to Evaluate HLX37 (Recombinant Human Anti-PD-L1 and Anti-VEGF Bispecific Antibody) in Combination With Chemotherapy Versus Pembrolizumab in Combination With Chemotherapy for First-Line Therapy of Advanced Non-Small Cell Lung Cancer

Sponsor
Shanghai Henlius Biotech (Industry)
Enrolment
1,438 planned
Conditions
NSCLC (Advanced Non-small Cell Lung Cancer)
Interventions
Investigational drug: HLX37 dose1, IV, Q3W; PEMBROLIZUMAB (alone or when added to a regimen above); Carboplatin (Investigator discretion); Paclitaxel or Nab-Paclitaxel; Pemetrexed (1); Investigational drug: HLX37 dose2, IV, Q3W
Ages
children
Registry
NCT07865910

Full record on ClinicalTrials.gov

From the registry

This is a Randomized, Double-Blind, Multicenter, Phase II/III Study to Evaluate HLX37 (Recombinant Human Anti-PD-L1 and Anti-VEGF Bispecific Antibody) in Combination with Chemotherapy Versus Pembrolizumab in Combination with Chemotherapy for First-Line Therapy of Advanced Non-Small Cell Lung Cancer.The first phase of this study is a Phase II trial, with Substudy A enrolling approximately 90 participants and Substudy B enrolling approximately 90 participants. Based on your disease pathology type, the investigator will determine which substudy you are enrolled in. Eligible participants will be randomly assigned to one of three treatment groups in a 1:1:1 ratio (similar to flipping a coin or drawing names from a hat), giving each participant an equal 1/3 chance of being assigned to any given group. Within each substudy, approximately one-third of participants will receive HLX37 at dose1combined with chemotherapy, one-third will receive HLX37 at dose2 combined with chemotherapy, and one-third will receive pembrolizumab at 200 mg combined with chemotherapy. All three treatment groups…

Primary outcomes

  • PFS assessed by BICR (Phase2&3)
  • ORR assessed by BICR (phse2)
  • OS (phase3)

History

  1. Study completion expected

  2. Primary completion expected

  3. Expected to start

  4. Registered