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A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer

NCT07318883 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2026-01-06

No results posted yet for this study

Summary

The study consists of two parts:

Part I is a randomized, double-blind, multicenter, parallel-controlled phase II clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with serplulimab and chemotherapy as first-line treatment in patients with sqNSCLC.

Part II is a randomized, double-blind, multicenter, parallel-controlled phase III clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy as first-line treatment in patients with sqNSCLC.

Conditions

  • Squamous NSCLC

Interventions

DRUG

HLX07

Intravenous infusion (IV), once every 3 weeks (Day 1 of each cycle \[D1\]).

DRUG

HLX07 placebo

Intravenous infusion (IV), once every 3 weeks (Day 1 of each cycle \[D1\]).

DRUG

Serplulimab

IV, once every 3 weeks (D1).

DRUG

Pembrolizumab

IV, once every 3 weeks (D1).

DRUG

Carboplatin

IV, once every 3 weeks (D1).

DRUG

Paclitaxel or Nab-Paclitaxel

Paclitaxel: IV, once every 3 weeks (D1). Nab-paclitaxel: IV, once every 3 weeks (D1, 8, 15).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2031-01-31
Completion
2031-01-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07318883 on ClinicalTrials.gov