Camrelizumab Combination With SBRT and Concurrent Chemotherapy Treated Stage IV Oligometastatic Non-small Cell Lung Cancer

Sponsor
Sichuan Cancer Hospital and Research Institute
Study ID
NCT05472467
Phase
PHASE2
Status
Unknown

Conditions

  • Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Camrelizumab — DRUG
    200mg IV Q3W. Every three weeks is a cycle
  • stereotactic body radiation therapy — RADIATION
    stereotactic body radiation therapy for Oligometastases 35Gy/5f(7.0Gy/f,5f per week)
  • Chemotherapy — DRUG
    Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles. Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles.

Study Details

This study evaluated the effectiveness and safety of Camrelizumab combination with SBRT and concurrent chemotherapy treated stage IV oligometastatic non-small cell lung cancer

Key Dates

Start date
Dec 21, 2021
Status verified
Jul 2022
Primary completion
Dec 20, 2023
Completion
Dec 20, 2023

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Immunotherapy combined with Stereotactic Body Radiation Therapy
    1. Camrelizumab： 200mg IV Q3W 2. Chemotherapy：Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles. Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles. 3. Stereotactic Body Radiation Therapy(SBRT) for Oligometastatic the total dose 35Gy/5f(7.0Gy/f,5f per week)。

Primary Outcome Measure

ORR [ Time Frame: up to 3 years ]

Central Contacts

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