Clinical trial · Interventional
A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210 Combination With BP102 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Whose PD-L1 Positive and EGFR/ALK Wild Type.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): changes in the R\&D strategy
Summary
Brief summary (as posted)
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have Stage IIIB\~IV non-squamous NSCLC. The primary end points are ORR and PFS. In this study, subjects will receive SHR-1210 combined with BP102 until progression or unacceptable toxicity (SHR-1210 or BP102 for a maximum of 2 years).
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 |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BP102 | Drug | Bevacizumab | ALIAS |
| SHR-1210 | Drug | Camrelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1210+BP102
- description
- Subjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity.
- interventionNames
- Drug: SHR-1210
- Drug: BP102
Primary outcomes (2)
- measure
- Objective response rate (ORR)
- timeFrame
- up to approximately 1 year
- description
- ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
- measure
- Progression-Free Survival (PFS)
- timeFrame
- up to approximately 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1; * Subjects who are chemotherapy naive and have Stage IIIB-IV non-squamous NSCLC; * Gene diagnostic tests must show that subjects are with wild type of EGFR, ALK and ROS1; * Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening; * No prior systemic treatment; * Adequate hematologic and end organ function; * Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 6 months after the last dose Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception from screening through 6 months after the last dose. Exclusion Criteria: * Significant cardiovascular disease; * Prior treatment with immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies; * History of autoimmune disease; * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome; * Severe infection within 4 weeks prior to randomization; * Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study; * Major surgical procedure within 4 weeks prior to randomization; * History of hemoptysis within 12 weeks prior to randomization; * Inadequately controlled hypertension; * Evidence of bleeding diathesis or coagulopathy; * Prior allogeneic bone marrow transplantation or solid organ transplant; * Positive test for HIV, and patients with active hepatitis B or hepatitis C.
References
Publications (0)
Data not yet available