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 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: HLX07-sqNSCLC301
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• ORR assessed by BICR (part I)

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

  Assessed up to appoximately 6 months from enrollment

• 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)

  Assessed up to appoximately 16 months from enrollment

• 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)

  Assessed up to appoximately 23 months from enrollment

• OS (part II)

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

  Assessed up to appoximately 42 months from enrollment

Secondary Outcomes (11)

• DCR (part I)

  Assessed up to appoximately 6 months from enrollment

• OS (part I)

  Assessed up to appoximately 35 months from enrollment

• DOR (part I)

  Assessed up to appoximately 35 months from enrollment

• ORR assessed by investigator (part I)

  Assessed up to appoximately 6 months from enrollment

• PFS assessed by investigator (part I)

  Assessed up to appoximately 16 months from enrollment

Study Arms (4)

Part I (phase 2)-Group A

EXPERIMENTAL

HLX07 + serplulimab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with HLX07 in combination with serplulimab, with serplulimab administered for up to 2 years.

Drug: HLX07; Drug: Serplulimab; Drug: Carboplatin; Drug: Paclitaxel or Nab-Paclitaxel

Part I (phase 2)-Group B

ACTIVE COMPARATOR

Placebo + serplulimab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with placebo in combination with serplulimab, with serplulimab administered for up to 2 years.

Drug: HLX07 placebo; Drug: Serplulimab; Drug: Carboplatin; Drug: Paclitaxel or Nab-Paclitaxel

Part II (phase 3)-Group A

EXPERIMENTAL

HLX07 + serplulimab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with HLX07 in combination with serplulimab, with serplulimab administered for up to 2 years.

Drug: HLX07; Drug: Serplulimab; Drug: Carboplatin; Drug: Paclitaxel or Nab-Paclitaxel

Part II (phase 3)-Group B

ACTIVE COMPARATOR

Placebo + pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with placebo in combination with pembrolizumab, with pembrolizumab administered for up to 2 years.

Drug: HLX07 placebo; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel or Nab-Paclitaxel

Interventions

HLX07 DRUG

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

Part I (phase 2)-Group A; Part II (phase 3)-Group A

HLX07 placebo DRUG

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

Part I (phase 2)-Group B; Part II (phase 3)-Group B

Serplulimab DRUG

IV, once every 3 weeks (D1).

Also known as: HLX10

Part I (phase 2)-Group A; Part I (phase 2)-Group B; Part II (phase 3)-Group A

Pembrolizumab DRUG

IV, once every 3 weeks (D1).

Also known as: Keytruda

Part II (phase 3)-Group B

Carboplatin DRUG

IV, once every 3 weeks (D1).

Part I (phase 2)-Group A; Part I (phase 2)-Group B; Part II (phase 3)-Group A; Part II (phase 3)-Group B

Paclitaxel or Nab-Paclitaxel DRUG

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

Part I (phase 2)-Group A; Part I (phase 2)-Group B; Part II (phase 3)-Group A; Part II (phase 3)-Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Note: Formalin-fixed tumor samples (paraffin blocks or unstained sections, meeting the quality control criteria for testing) collected from lesions that have not received radiotherapy at or after the diagnosis of locally advanced/recurrent or distant metastatic squamous non-small cell lung cancer (sqNSCLC) (from the most recent surgery or biopsy, preferably within half a year prior to randomization) should be provided. Relevant pathology reports must also be provided for the above specimens. For detailed requirements for tissue samples, see the Laboratory Operation Manual.
• Absence of prior systemic treatment for locally advanced/recurrent or distant metastatic sqNSCLC. Patients who have received prior adjuvant or neoadjuvant therapy are allowed to be enrolled if the adjuvant/neoadjuvant therapy has been completed at least 6 months before the diagnosis of locally advanced/recurrent or distant metastatic sqNSCLC.
• Prior non-systemic anti-tumor therapy or Chinese herbal anti-tumor therapy must have ended for ≥ 2 weeks before randomization, and treatment-related AEs have resolved to Grade ≤ 1 according to Common Terminology Criteria for Adverse Events (CTCAE) 6.0 (except for Grade 2 alopecia).
• At least one measurable target lesion assessed by BICR as per RECIST v1.1 within 4 weeks before randomization.
• Note: Measurable target lesions cannot be selected from prior radiotherapy sites. A lesion at the prior radiotherapy site may be selected as the target lesion if it is the only available lesion, and should provide the imaging data of the lesion before and after an unequivocal progression after the radiotherapy.
• An ECOG performance status score of 0 or 1 within 7 days prior to randomization.
• Life expectancy ≥ 12 weeks.
• Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-); if HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be \< 2,500 copies/mL or 500 IU/mL or within the normal range of this site.
• HCV antibody (-); if HCV antibody (+), HCV-RNA testing must be negative before enrollment. Participants co-infected with hepatitis B and C will be excluded (tested positive for HBsAg or HBcAb and positive for HCV antibody).
• Adequate major organ functions as defined by the following criteria
• Female patients must meet one of the following conditions:

You may not qualify if:

• 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.
• Note: If the EGFR, ALK, ROS1 and other actionable driver oncogenes statuses are unknown, testing is not mandatory, unless there are high-risk factors (such as non-smoking female patients), under which circumstances testing of EGFR and other mutations may be considered.
• 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.
• Uncontrollable pleural effusion, pericardial effusion, or ascites.
• Active central nervous system (CNS) metastases and/or carcinomatous meningitis known or diagnosed at screening. However, the following patients may be enrolled:
• Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no requirement for glucocorticoid therapy, and lesion size ≤ 1.5 cm) may be enrolled, but are required to receive regular brain imaging as a site of lesion.
• Patients with treated brain metastases that have been stable for at least 1 month, with no evidence of new or enlarging brain metastases, and with glucocorticoid discontinued ≥ 3 days prior to randomization.
• Stable brain metastases should be confirmed before randomization.
• Spinal cord compression that has not been cured with radical surgery and/or radiotherapy.
• Clinically significant hemoptysis complicated with superior vena cava syndrome.
• Myocardial infarction and poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula) within 6 months prior to randomization;
• NYHA Class III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 50% by echocardiography.
• Inadequately controlled hypertension (defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg), with a history of hypertensive crisis or hypertensive encephalopathy.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

HLX07; pembrolizumab; Carboplatin; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Qinghua Huang

CONTACT

+86-021-33395800; Tammy_Huang@henlius.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)