Clinical trial · Interventional
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC
A Phase II Clinical Trial of SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined With Hypofraction Radiotherapy in Patients With Previously Treated Oligometastatic NSCLC
- 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 is a phase II clinical trial of SHR-1210 (an anti-PD-1 Inhibitor) simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC. It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.
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 |
|---|---|---|---|
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1210 | Drug | Camrelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1210 +Hypofraction radiotherapy
- description
- SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
- interventionNames
- Drug: SHR-1210
Primary outcomes (2)
- measure
- Clinically significant toxicity
- timeFrame
- First cycle (28 days)
- description
- above grade 3 AEs
- measure
- 6-month-PFS
- timeFrame
- From the start of treatment to 6 months.
- description
- 6-month-progression free survival rate
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects will voluntarily participate in this study and sign informed consent. * NSCLC subject with 1 to 5 distant metastatic lesions in stage IV. * No clear driven genes (including but not limited to EGFR, ALK). * Previously received more than 1 chemotherapy regimen and progressed/recurred. * At least one lesion is suitable for hypofraction radiotherapy. * There is at least one measurable lesion. * 18 to 75 years old * ECOG 0-1 * The function of vital organs meets the following requirements. ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALB≥3g/dL, TSH ≤ULN, Bilirubin ≤ 1 times ULN; ALT and AST ≤1.5 times ULN. AKP ≤ 2.5 times ULN. CREA ≤1.5 times ULN or CCr≥60mL/min。 * The estimated survival period is more than 3 months. * Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment. Exclusion Criteria: * The subjects had any history of autoimmune disease or active autoimmune disease. * Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry. * Subjects with severe allergic reactions to other monoclonal antibodies. * The subjects had a central nervous system metastases of clinical symptoms. * Central squamous cell lung carcinoma. * Imaging (CT or MRI) shows that tumors invade large blood vessels or are indistinct with blood vessels. * Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator. * Failing to properly control the clinical symptoms or disease of the heart. * Subjects had active infections. * Subjects may receive other systemic antitumor therapy during the study period. * Other clinical trials of drugs were used in the first four weeks of the first medication.
References
Publications (0)
Data not yet available