Clinical trial · Interventional
A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC
An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
NCT04672369CI-TRIAL-00067336completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI939 | Biological | — | UNRESOLVED |
| Sintilimab | Biological | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IBI939 in combination with Sintilimab
- interventionNames
- Biological: IBI939
- Biological: Sintilimab
- type
- ACTIVE_COMPARATOR
- label
- sintilimab
- interventionNames
- Biological: Sintilimab
Primary outcomes (1)
- measure
- Objective response rate(ORR)
- timeFrame
- 6 months
- description
- Proportion of subjects with complete response(CR) or partial response(PR).
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed the Informed Consent Form; 2. Male or female ≥ 18 and≤75 years of age; 3. Life expectancy ≥ 12 weeks; 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1 5. Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements. 6. Histologically or cytologically confirmednon-small cell lung cancer Exclusion Criteria: 1. Previous exposure to immune-mediated therapy; previous use of antitumor vaccine; 2. Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug; 3. Received any investigational agent within 4 weeks prior to the first dose of study drug; 4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose; 5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
References
Publications (0)
Data not yet available
No reference posted for this study.