A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

NCT07174908 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: IN10018-023
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 11

Brief Summary

This is a multicenter, randomized, open-label, phase III clinical study, to evaluate the efficacy and safety of IN10018 in combination with D-1553 as compared to anti-PD-1 monoclonal antibody (mAb) in combination with platinum and pemetrexed as the first-line treatment for the locally advanced or metastatic KRASG12C mutation-positive non-squamous non-small cell lung cancer (NSCLC).

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by blinded independent central review (BICR).

  up to 36 months

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  up to 36 months

• Overall Survival (OS)

  up to 60 months

• Disease Control Rate (DCR)

  Up to 36 months

• Duration of Response (DoR)

  up to 36 months

• PFS

  up to 36 months

Other Outcomes (4)

• PK: Cmax of IN10018 and D-1553

  up to 36 months

• PK: Cmin of IN10018 and D-1553

  up to 36 months

• PK: AUC of IN10018 and D-1553

  up to 36 months

Study Arms (2)

IN10018 plus D-1553

EXPERIMENTAL

Subjects receive IN10018 100mg orally once daily (QD) and D-1553 600mg orally twice daily (BID) on Days 1-21 of each 21-day cycle, until disease progression or unacceptable toxicity.

Drug: IN10018 in combination with D-1553

Tislelizumab plus Platinum and Pemetrexed

ACTIVE COMPARATOR

Subjects receive Tislelizumab 200mg intravenously (IV) once every 3 weeks (Q3W) until disease progression, plus Carboplatin (AUC = 5 mg/mL/min, Q3W, IV) or Cisplatin (75 mg/m², Q3W, IV) for up to 4 cycles, in combination with Pemetrexed (500 mg/m², Q3W, IV) until disease progression.

Drug: anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed

Interventions

IN10018 in combination with D-1553 DRUG

IN10018 100mg QD PO and D-1553 600mg BID PO, 21days per cycle

IN10018 plus D-1553

anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed DRUG

Tislelizumab 200mg Q3W IV + Carboplatin AUC 5 mg/mL/min or Cisplatin 75mg/m² Q3W IV+ Pemetrexed 500mg/m² Q3W IV

Tislelizumab plus Platinum and Pemetrexed

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide informed consent and comply with study requirements
• Has histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC
• Aged 18-80 years at the time of consent
• Has KRAS G12C mutation confirmed by central laboratory
• Has not received prior systemic therapy for advanced or metastatic NSCLC
• Has at least one measurable lesion per RECIST v1.1
• ECOG performance status of 0-1
• Has adequate organ function
• Life expectancy ≥3 months in the opinion of the Investigator
• Male and female subjects of reproductive potential must agree to use effective contraception during and for 6 months after treatment

You may not qualify if:

• Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine)
• Has active or untreated CNS metastases or carcinomatous meningitis
• Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors
• Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)
• Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy
• Has history of another malignancy within 5 years, except those curatively treated and considered low risk (e.g., basal cell carcinoma, cervical carcinoma in situ)
• Has gastrointestinal conditions that may interfere with absorption of oral drugs (if applicable)
• Has known active hepatitis B, hepatitis C, or HIV infection
• Has received a live vaccine within 30 days before first dose of study drug
• Pregnant or breastfeeding women
• Has psychiatric or substance abuse disorders that would interfere with study compliance
• Is participating in another interventional clinical study
• Any condition that, in the opinion of the Investigator, would interfere with participation or study results

Sponsors & Collaborators

• InxMed (Shanghai) Co., Ltd.: lead

Study Sites (11)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Union Hospital Tongji Medidcal College Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

NOT YET RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

RECRUITING

First Affiliated Hospital of Gannan Medical University

Gannan, Jiangxi, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Platinum; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; 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

Study Officials

• Zhengbo Song Professor, Doctor

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Shun Lu Professor, Doctor

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Fang Project Manager, bachelor

CONTACT

86-15933968623; shu.fang@inxmed.com

Jack Zhang Clinical Trial Manager, bachelor

CONTACT

jack.zhang@inxmed.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: August 29, 2025
• First Posted: September 16, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 3, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)