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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

ConditionSquamous NSCLC
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Henlius Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patients voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study procedures.

Male or female, aged 18 years or older at the time of signing the ICF.

Histologically confirmed with stage IIIB/IIIC or IV (AJCC 8th edition) squamous NSCLC ineligible for surgery or radical radiotherapy.

Patients must provide sufficient tumor tissues that meet the quality requirements for the determination of EGFR and PD-L1 expression levels.

Disqualifiers

Histologically confirmed non-sqNSCLC. Mixed tumors will be classified by the predominant cell type. Patients with small cell component or neuroendocrine carcinoma component are not eligible. For the non-small cell histology, patients with squamous component that is predominant (e.g., adenosquamous) are eligible.

Known EGFR-sensitizing mutation, ALK/ROS1 gene rearrangement, or other actionable driver oncogenes for which there are locally approved targeted first-line therapies.

Other malignancies within 5 years or active. Patients with localized tumors that have been cured, such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ, are eligible.

Scheduled or previous organ or bone marrow transplantation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX07

    Drug

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

  • HLX07 placebo

    Drug

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

  • Serplulimab

    Drug

    IV, once every 3 weeks (D1).

  • Pembrolizumab

    Drug

    IV, once every 3 weeks (D1).

  • Carboplatin

    Drug

    IV, once every 3 weeks (D1).

  • Paclitaxel or Nab-Paclitaxel

    Drug

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

Treatment groups

720 Participants
are divided into 4 treatment groups
Group A: Part I (phase 2)-Group AExperimental treatment 4 interventions
Group B: Part I (phase 2)-Group BActive comparator 4 interventions
Group C: Part II (phase 3)-Group AExperimental treatment 4 interventions
Group D: Part II (phase 3)-Group BActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

ORR assessed by BICR (part I)

Defined as the proportion of participants who achieve a best overall response of CR or PR

Time frame
Assessed up to appoximately 6 months from enrollment
2

PFS assessed by BICR (part I)

Defined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)

Time frame
Assessed up to appoximately 16 months from enrollment
3

PFS assessed by BICR (part II)

Defined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)

Time frame
Assessed up to appoximately 23 months from enrollment
4

OS (part II)

Defined as the time from randomization to death due to any cause

Time frame
Assessed up to appoximately 42 months from enrollment

Secondary outcomes

1

DCR (part I)

Defined as the proportion of participants who achieve a best overall response of CR or PR or an SD

Time frame
Assessed up to appoximately 6 months from enrollment
2

OS (part I)

Defined as the time from randomization to death due to any cause

Time frame
Assessed up to appoximately 35 months from enrollment
3

DOR (part I)

Defined as the time from the first documented objective response to PD or death

Time frame
Assessed up to appoximately 35 months from enrollment
4

ORR assessed by investigator (part I)

Defined as the proportion of participants who achieve a best overall response of CR or PR

Time frame
Assessed up to appoximately 6 months from enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: