Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05504278

Efficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

Advanced Non-Small Cell Lung Cancer Clinical Trial

Official title:
An Open-label, Multi-center Phase Ib/III Study Evaluating the Efficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

Clinical Trial Summary

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with Sintilimab± chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.

Clinical Trial Description

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with Sintilimab± chemotherapy. There will be four cohorts of subjects, all of whom have KRAS G12C mutation and have advanced or metastatic NSCLC. Three cohorts (A, C and D) are treated with IBI351+Sintilimab, IBI351+Sintilimab+pemetrexed, or IBI351+Sintilimab+pemetrexed+cis-platinum/carboplatin, respectively, as first-line therapy. Cohort B enrolles subjects who is intolerant or has failed in standard-of care treatment,and is treated with IBI351+Cetuximab. IBI351 is an orally available small molecule inhibitor of KRAS G12C. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05504278
Study type Interventional
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact Xiaodong Sun
Phone 0512-69566088
Email xiaodong.sun@innoventbio.com
Status Recruiting
Phase Phase 1
Start date September 20, 2022
Completion date July 31, 2027
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04263051 - Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung Cancer Phase 2
Recruiting NCT05489731 - VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer Phase 1
Completed NCT01240447 - Immunotherapy With Racotumomab Versus Support Treatment in Advanced Non-small Cell Lung Cancer Patients Phase 2
Completed NCT00737867 - Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer Phase 3
Recruiting NCT05482568 - A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Recruiting NCT06043973 - Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance Phase 3
Completed NCT00948675 - Study of Participants With Advanced Non-Small Cell Lung Cancer Phase 3
Active, not recruiting NCT03681483 - RO5126766 for Patients With Advanced KRAS-Mutant Lung Cancer Phase 1
Terminated NCT05001724 - KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent Phase 2/Phase 3
Recruiting NCT05099172 - First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) Phase 1/Phase 2
Recruiting NCT02133196 - T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer Phase 2
Recruiting NCT00874328 - A Study of TS-1 Plus Irinotecan and Cisplatin (IP) for Patients With Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Completed NCT00487669 - Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for Advanced Non-small Cell Lung Cancer (NSCLC) Phase 2
Active, not recruiting NCT03516981 - A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) Phase 2
Recruiting NCT03334864 - Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)
Terminated NCT00783471 - Docetaxel Intermittent-Erlotinib (Tarceva®) In Metastatic Non Small Cell Lung Cancer (NSCLC) Phase 2
Completed NCT00330746 - CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer Phase 2
Completed NCT03117335 - Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer Phase 3
Terminated NCT00345059 - The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer Phase 3
Completed NCT01980212 - Tumor Relapsed Study of Serum Trxr Activity in Advanced Non-small Cell Lung Cancer