> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-ibi351-in-combination-with-3c278713-9c4b-4497-930c-33419d7327bc > Record changed: 2026-10-13 # Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation NCT05504278 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) Participants 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) Lead sponsor Innovent Biologics (Suzhou) Co. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) Start date 2022-09-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Title and summary **Summary** This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Short title** Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Official title** An Open-label, Multi-center Phase Ib/III Study Evaluating the Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Dates **Completion date** 2027-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **First posted** 2022-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Registry last updated** 2025-01-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Primary completion date** 2025-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Start date** 2022-09-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Size and sites **Participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Planned participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Lead sponsor** Innovent Biologics (Suzhou) Co. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Identifiers **Registry ID** NCT05504278 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **ClinicalTrials.gov ID** NCT05504278 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Outcomes ### Primary outcomes 1. Number of participants with dose limiting toxicity Timeframe: 12 months Number of participants with dose limiting toxicity in the dose escalation period 2. Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents Timeframe: 24 months Objective response rate per RECIST v1.1 3. Safety indicators during the introduction phase for IBI351 combination treatment : Timeframe: 24 months Number of participants with Adverse events (AE), Treatment Emergent Adverse events (TEAE), treatment-related Adverse events (TEAE), TRAE) and the incidence of Serious Adverse events (SAE) (CTCAE v5.0 standard), with abnormal vital signs, abnormal physical exams, abnormal laboratory results and abnormal 12-lead electrocardiogram ### Secondary outcomes 1. Evaluate plasma peak concentration of IBI351 Timeframe: 12 months Cmax 2. Evaluate area under the plasma concentration-time curve (AUC) of IBI351 Timeframe: 12 months AUC 3. Evaluate terminal half-life (t1/2) of IBI351 Timeframe: 12 months t1/2 4. Evaluate clearance of IBI351 from the plasma Timeframe: 12 months CL/F 5. Evaluate distribution of IBI351 Timeframe: 12 months V/F 6. Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents with other index Timeframe: 24 months PFS, DCR,DOR, TTR per RECIST v1.1; OS 7. Number of subjects with adverse events of interest Timeframe: 24 months AE 8. Number of subjects with treatment-related adverse events Timeframe: 24 months TRAE 9. Number of subjects with serious adverse events Timeframe: 24 months SAE 10. Number of subjects with treatment-emergent adverse events Timeframe: 24 months TEAE 11. Overall Survival Timeframe: 24 months OS Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation 2. Unresectable or metastatic disease 3. Adequate organ function 4. Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously. ### Exclusion criteria 1. History of intestinal disease or major gastric surgery or inability to swallow oral medications 2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510). 3. Active brain metastases. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Sites - Jilin Province Cancer HospitalJilin City, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504278) ## Related records ### Drugs (5) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) - [Platinum](https://trialight.com/data/asset/platinum-418ce0fe-dd28-40a8-8225-5d12ccc291d1.md) - [Sintilimab](https://trialight.com/data/asset/sintilimab-e2618eaf-967e-401c-aed4-7546875a6d3e.md) ### Lead sponsors (1) - [Innovent Biologics (Suzhou) Co. Ltd.](https://trialight.com/data/company/innovent-biologics-suzhou-co-ltd-cd395d6d-f2bc-41a8-9a5c-6d6d1871bceb.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (5) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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