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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2023-07-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Durvalumab therapy

Chemo+Durvalumab (PD-L1 monoclonal antibody)1500 mg every 3 weeks \[q3w\] intravenously \[iv\] for 4 cycles, then SBRT 50-60 Gy/≤10f + Durvalumab 1500 mg q4w, then Durvalumab 1500 mg q4w for up to 24 months or until progression or other discontinuation criteria are met.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

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

Intervention Type DRUG

paclitaxel+carboplatin or pemetrexed+cisplatin

stereotactic body radiotherapy (SBRT)

Intervention Type RADIATION

SBRT total doses of 50-60Gy/≤10F

Interventions

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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

Intervention Type DRUG

the first line chemotherapy for metastatic NSCLC

paclitaxel+carboplatin or pemetrexed+cisplatin

Intervention Type DRUG

stereotactic body radiotherapy (SBRT)

SBRT total doses of 50-60Gy/≤10F

Intervention Type RADIATION

Other Intervention Names

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IMFINZI

Eligibility Criteria

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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一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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No