Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Pilot Study of Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04255836
• Other study ID #: ESR-19-20392
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 30, 2020
• Est. completion date: July 30, 2023

Study information

• Verified date: January 2020
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase II, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic non-small cell lung cancer (NSCLC).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: July 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer

• =3 metastatic organs and =5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node

• metastasis?group lymph node region will be classified as one metastatic lesion)

• Tissue biopsy prior to treatment

• ECOG performance score 0-1

Exclusion Criteria:

• EGFR mutation or ALK positive.

• Evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia.

• Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.

• Previous treatment with antibody against pd -1, pd - L1, pd - L2, CD137 or CTLA-4 (including ipilimumab or any antibody or drug against T cell co-stimulation or checkpoint pathway).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Durvalumab
Durvalumab 1500mg q3w combined with chemotherapy for 4 cycles, then 1500mg q4w combined with SBRT, then 1500mg q4w for PD or up to 24 months
• the first line chemotherapy for metastatic NSCLC
paclitaxel+carboplatin or pemetrexed+cisplatin

Radiation:
• stereotactic body radiotherapy (SBRT)
SBRT total doses of 50-60Gy/=10F

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC	up to 2 years
Secondary	Safety (AESI, AEs/SAEs)	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	up to 2 years
Secondary	To assess the treat failure patterns	Treat failure patterns including local failure and distant metastasis	up to 2 years
Secondary	Objective response rate(ORR)	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.	up to 2 years
Secondary	and OS Overall Survival(OS)	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.	up to 2 years