A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

NCT07178795 | Recruiting Phase 3 DMC

• 1 other identifier: BL-M07D1-306
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a registrational phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with first-line treatment of HER2-mutant advanced or metastatic non-squamous non-small cell lung cancer.

Conditions

Non-squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

  Up to approximately 24 months

Secondary Outcomes (6)

• Overall survival (OS)

  Up to approximately 24 months

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (2)

BL-M07D1

EXPERIMENTAL

Participants receive BL-M07D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-M07D1

Pembrolizumab-platinum chemotherapy

ACTIVE COMPARATOR

Participants receive Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1

Pembrolizumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Pembrolizumab-platinum chemotherapy

Pemetrexed DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Pembrolizumab-platinum chemotherapy

Carboplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Pembrolizumab-platinum chemotherapy

Cisplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Pembrolizumab-platinum chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Age at the time of signing the informed consent form is ≥18 years and ≤75 years, regardless of gender;
• Expected survival time ≥12 weeks;
• Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer;
• HER2 functional mutation confirmed by a central laboratory;
• Provide the most recent tumor tissue meeting the requirements for biomarker testing by the central laboratory;
• Must have at least one measurable target lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from previous anti-tumor treatments has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• Organ function levels must meet the requirements;
• For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days prior to the start of treatment, and the serum pregnancy test must be negative. They must not be breastfeeding. All enrolled patients (regardless of gender) should take adequate and highly effective contraceptive measures throughout the treatment period and for 7 months after the end of treatment.

You may not qualify if:

• Having undergone surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;
• Pathological findings indicating non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
• Concurrent presence of other driver gene mutations for which targeted drug therapy is available and approved for NSCLC indications;
• Previous treatment with HER2-targeted therapy or ADC drugs with camptothecin derivatives as the toxin;
• History of severe cardiovascular or cerebrovascular diseases within the past 6 months prior to screening;
• Concurrent pulmonary diseases leading to severe impairment of lung function;
• History of ILD/interstitial pneumonia requiring steroid treatment or current diagnosis of ILD/interstitial pneumonia;
• Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
• Diagnosis of other primary malignancies within 5 years prior to the first dose;
• Newly developed deep vein thrombosis within 14 days prior to screening;
• Hypertension poorly controlled by antihypertensive medications;
• Patients with central nervous system (CNS) metastases, carcinomatous meningitis (leptomeningeal metastases), and/or spinal cord compression;
• Patients with a history of severe allergies to any excipients or components of the investigational drug;
• History of autologous or allogeneic stem cell transplantation or organ transplantation;
• Positive human immunodeficiency virus antibody, active hepatitis B virus infection, liver cirrhosis, or hepatitis C virus infection;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

pembrolizumab; Pemetrexed; Carboplatin; Cisplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)