Prospective Phase ii Clinical Study of the Efficacy and Safety of Durvalumab Combined With Consolidation Radiotherapy After First-line Treatment With Platinum-containing Chemotherapy in Extensive Stage Small Cell Lung Cancer With Oligometastases (1-5 Lesions)

Affiliated Cancer Hospital & Institute of Guangzhou Medical University0 sites58 target enrollmentAugust 1, 2022

ConditionsLung Cancer Extensive-stage Small-cell Lung Cancer Radiotherapy

InterventionsDurvalumab + carboplatin/cisplatin + etoposide Consolidation radiotherapy Durvalumab

DrugsDurvalumab + carboplatin/cisplatin + etoposide Durvalumab

Overview

Phase: Phase 2
Intervention: Durvalumab + carboplatin/cisplatin + etoposide
Conditions: Lung Cancer
Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Enrollment: 58
Primary Endpoint: overall survival time
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

In patients with oligometastatic (1-5 lesions) extensive-stage small cell lung cancer, to explore the efficacy and safety of Durvalumab immunotherapy combined with chemotherapy followed by consolidation radiotherapy, to provide scientific basis for the formulation of the best comprehensive treatment plan in the future.

Detailed Description

To explore the efficacy and safety of consolidation radiotherapy after Durvalumab immunotherapy combined with chemotherapy in patients with oligometastatic small cell lung cancer (1-5 lesions), so as to provide scientific basis for making the best comprehensive treatment plan in the future.All subjects will receive the following treatments: 1. Induction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab + carboplatin/cisplatin + etoposide, intravenous drip 2. Consolidation radiotherapy period: radiotherapy for primary chest lesions + oligometastatic lesions. 3. Maintenance phase (administered every 4 weeks): Durvalumab intravenous infusion.

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

August 1, 2027

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is the longer), systemic immune stimulants (including but not limited to interferon, interleukin-2, tumor necrosis factor) are used (cancer vaccines are allowed in previous treatments)
•Within 14 days before the first administration of the drug, any Chinese herbal medicine used to control cancer was used.
•Any disease that must be treated with corticosteroids (prednisone \> 10mg/ days or equivalent) or other immunosuppressive drugs within 14 days before enrollment Note: patients who have used or have used any of the following steroid regimens can be selected: epinephrine replacement steroids (prednisone ≤ 10mg/ days or equivalent). Inhaled corticosteroids with very low local, ocular, articular, nasal or systemic absorption; prophylactic use of prescription corticosteroids in a short course (≤ 7 days) or for the treatment of non-autoimmune diseases (such as delayed anaphylaxis caused by contact allergens)
•Live vaccine is given within 4 weeks before joining the group. Note: seasonal influenza vaccine is usually an inactivated vaccine, and patients who receive such vaccine are allowed to join the group. The intranasal influenza vaccine is a live vaccine, and patients vaccinated with such vaccine are not allowed to enter the group.
•Any major surgery requiring general anesthesia was performed within 28 days before enrollment.
•Previous allogeneic stem cell transplantation or organ transplantation
•Clinically uncontrolled pericardial effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before randomization. Uncontrolled brain metastasis with active leptomeningeal disease:
•patients with asymptomatic central nervous system (CNS) metastasis during the screening phase can be selected if all of the following conditions are met: brain imaging examinations during the screening phase show that there is no evidence of mid-term progression between completion of immunotherapy combined with chemotherapy induction therapy and enrollment; no continuous use of corticosteroids for CNS disease; and permitting stable doses of anticonvulsant therapy.
•Suffer from active autoimmune diseases or have a history of autoimmune diseases that may recur. Note: patients with the following diseases can be further screened: well-controlled type 1 diabetic hypothyroidism (only thyroid hormone replacement therapy can be controlled); well-controlled celiac disease; any other diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia) that are not expected to recur without external triggers
•Has suffered from interstitial lung disease or non-communicable pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.