IBI363 - Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer | Phase 2 | Co-Diagnostics, Inc. | BiopharmaWatch

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IBI363

Phase 2

Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Sep 30, 2025

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker

Total Trials1

Total Enrollment170

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT07122687	IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer	PHASE2	RECRUITING	170	—	—	Aug 26, 2025	Apr 30, 2030	Sep 30, 2025	1	China

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Study Endpoints

Primary Endpoints

Pathologic Complete Response (pCR) rate

Up to approximately 8 weeks following completion of neoadjuvant treatment

pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.

Safety parameters: the incidence of all adverse events (AEs)

up to 90 days after the last dose

Safety parameters: the incidence of treatment-emergent adverse events (TEAEs)

up to 90 days after the last dose

Safety parameters: the incidence of immune-related adverse events (irAEs)

up to 90 days after the last dose

Safety parameters: the incidence of adverse events of special interest (AESIs)

up to 90 days after the last dose

Safety parameters: the incidence of serious adverse events (SAE)

up to 90 days after the last dose

Safety parameters: the relatedness of infusion-related reactions (IRRs) to the investigational product and their severity

up to 90 days after the last dose

Safety parameters: the surgery delay rate

Up to approximately 8 weeks following completion of neoadjuvant treatment

Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests,, routine urine tests, pregnancy tests，ECG, etc

up to 90 days after the last dose

Secondary Endpoints

Event Free Survival (EFS)

Up to approximately 5 years

Major Pathological Response (mPR) Rate

Up to approximately 8 weeks following completion of neoadjuvant treatment

Objective Response Rate （ORR）Rate

Up to approximately 5 years

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
IBI363	EXPERIMENTAL	Neoadjuvant Treatment period: up to 3 cycles of IBI363 plus platinum-based chemotherapy prior to surgery.
Keytruda	ACTIVE_COMPARATOR	Neoadjuvant Treatment period: up to 3 cycles of Keytruda plus platinum-based chemotherapy prior to surgery.

Interventions

Name	Type	Description
Pemetrexed	DRUG	500 mg/m2 D1 IV Q3W
Cisplatin	DRUG	75 mg/m2 D1 IV Q3W
IBI363	DRUG	1.5 mg/kg D1 IV Q3W
Carboplatin	DRUG	AUC 5 mg/ml/min D1 IV Q3W
Keytruda	DRUG	200mg D1 IV Q3W

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Eligibility Criteria

Age Range18 Years — 75 Years

SexALL

Healthy VolunteersNo

Study Sites1

Inclusion Criteria: 1. Males and Females, age ≥18 years and ≤75 years; 2. Histologically or cytologically confirmed primary non-squamous NSCLC: * Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8); * No administration of any anti-NSCLC therapy in the pre-operative period; * Be able to unde...

Countries:China

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