Clinical trial · Interventional
A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer
A Phase 3, Randomized Double-blind, Placebo-controlled, Multicenter Study of SHR-1701 in Combination With Bevacizumab and Chemotherapy in Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer With EGFR Mutation After Failure of TKIs
NCT05132413CI-TRIAL-00055237unknownPhase 3ClinicalTrials.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)
Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs
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 or Metastatic Non-squamous Non-small-cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin | Drug | — | UNRESOLVED |
| Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin | Drug | — | UNRESOLVED |
| SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- treatment group
- interventionNames
- Drug: SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo group 1
- interventionNames
- Drug: Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo group 2
- interventionNames
- Drug: Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: \- A subject must satisfy all of the following criteria to be considered for inclusion in the study: 1. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer. 2. Failed with prior EGFR-TKIs treatments. 3. Measurable disease, as defined by RECIST v1.1 4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1 5. Life expectancy ≥ 3 months 6. Adequate hematologic and end-organ function as defined in the protocol Exclusion Criteria: \- A subject who meets any of the following criteria will be excluded from study entry: 1. Histologically or cytologically confirmed mixed SCLC and NSCLC. 2. Symptomatic, untreated or active central nervous system metastases. 3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment 4. With any active autoimmune disease or history of autoimmune disease. 5. Inadequately controlled hypertension. 6. Tumour infiltration into the great vessels on imaging. 7. History of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment. 8. Uncontrolled tumour-related pain. 9. Patients with active hepatitis B or hepatitis C 10. Severe infections within 4 weeks prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.