SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC
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|ClinicalTrials.gov Identifier: NCT04106180|
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|NSCLC Stage IV||Drug: GM-CSF Drug: Sintilimab Radiation: SBRT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter, Phase II Single Arm Trial of SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC|
|Estimated Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2023|
|Experimental: SBRT + sintilimab + GM-CSF||
Patients will receive GM-CSF 125μg/m2 daily for 14 consecutive days after completing SBRT treatment.
Patients will receive Sintilimab 200 mg every 3 weeks up to 2 years after completing SBRT treatment.
Patients will receive SBRT for one previously unirradiated primary or metastatic lesion (size: 1-5cm). 24 Gy in 3 fractions (8Gy/Fx) administered once-daily for 3 consecutive days.
Other Name: Stereotactic body radiation therapy
- Overall Objective Response Rate [ Time Frame: At least 6 weeks after start of treatment ]ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Percentage of Participants With Adverse Events [ Time Frame: Two years ]Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
- Objective Response Rate (ORR) in Non-irradiated Lesion [ Time Frame: At least 6 weeks after start of treatment ]Objective Response Rate (ORR) in Non-irradiated Lesion was defined as the proportion of patients with at least 30% reduction from baseline in the longest diameter of any of non-irradiated target lesions defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time-point from the date of treatment initiation to the date of last follow-up.
- Overall Survival [ Time Frame: Two years ]OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
- Progression Free Survival [ Time Frame: Two years ]PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106180
|Contact: Zhengfei Zhu, MDemail@example.com|
|Contact: Jianjiao Ni, MDfirstname.lastname@example.org|
|Principal Investigator:||Zhengfei Zhu, MD||Fudan University|
|Study Director:||Xinghao Ai||Shanghai Chest Hospital|
|Study Director:||Zhengbo Han||Shengjing Hospital|
|Study Director:||Qian Chu||Tongji Hospital|
|Study Director:||Xiaorong Dong||Union Hospital|
|Study Director:||Lin Wu||Hunan Cancer Hospital|