NCT07833202

Brief Summary

This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P50-P75 for phase_3

Timeline
48mo left

Started Oct 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

2.5 years

First QC Date

September 13, 2026

Last Update Submit

September 22, 2026

Conditions

NSCLC

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).

    30 months

Secondary Outcomes (8)

  • Objective Response Rate (ORR)

    30 months

  • Overall Survival (OS)

    up to 60 months

  • Disease Control Rate (DCR)

    30 months

  • Duration of Response (DoR)

    30 months

  • PFS by investigator assessment

    up to 30 months

  • +3 more secondary outcomes

Study Arms (2)

Study Arm

EXPERIMENTAL

Sosimerasib in combination with IN10018

Drug: Sosimerasib in combination with IN10018

Control Arm

ACTIVE COMPARATOR

anti-PD-1 monoclonal antibody in combination with chemotherapy

Drug: Tislelizumab + Carboplatin + Pemetrexed

Interventions

Sosimerasib in combination with IN10018DRUG

Participants receive Sosimerasib in combination with IN10018 orally once daily (QD) in a 21-day cycle, until disease progression or unacceptable toxicity

Study Arm
Tislelizumab + Carboplatin + PemetrexedDRUG

Participants receive Tislelizumab Q3W IV until disease progression or up to 2 years, plus Carboplatin Q3W IV for up to 4 cycles, plus Pemetrexed Q3W IV until disease progression.

Control Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease.
  • Has KRAS G12C mutation confirmed by central laboratory.
  • Measurable disease according to RECIST 1.1.
  • An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.
  • Life expectancy ≥3 months in the opinion of the Investigator
  • Male and female participants of reproductive potential must agree to use effective contraception during and for 6 months after treatment

You may not qualify if:

  • Has another known driver mutation with approved first-line targeted therapy.
  • Participants with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
  • Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors.
  • History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
  • Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease.
  • Any condition that, in the opinion of the Investigator, would interfere with participation or study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

MeSH Terms

Interventions

tislelizumabCarboplatinPemetrexed

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Central Study Contacts

Jieting Zhao

CONTACT

021-60198525zhaojieting@jeyoupharma.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 13, 2026

First Posted

September 22, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

September 1, 2030

Last Updated

September 24, 2026

Record last verified: 2026-09

Locations

CN(1)