Efficacy and Safety of Sintilimab With or Without Radiotherapy in Patients With Recurrent or IV NSCLC (EGFR -, ALK -) After Failure of Platinum-based Chemotherapy: A Randomized,Open Labled, Phase II Clinical Study

Lung Neoplasms Clinical Trial

Official title:
Efficacy and Safety of Sintilimab With or Without Radiotherapy in Chinse Patients With Recurrent or IV NSCLC (EGFR -, ALK -) After Failure of Platinum-based Chemotherapy: A Randomized, Controlled, Phase II Clinical Study

Status Recruiting

Clinical Trial Summary

Lung cancer incidence and mortality have been increasing steeply in the past thirty years in the mainland of China. More than 80% of lung cancer is non-small cell lung cancer (NSCLC). More than 40% of NSCLC patients are found to be in stage IIIb or IV, which is not resectable. The 5-year survival rate for this group of patients is less than 5% in the SEER database. Currently, the NCCN guidelines recommend platinum-containing double-drug chemotherapy as the first- line standard of care for advanced NSCLC without driver gene mutations, and treatment options after failure of first-line chemotherapy are limited. Immune Checkpoint Inhibitors, ICIs provide new treatment options, and in addition, radiotherapy can also be used in selected patients with advanced NSCLC, especially in patients with oligo progression, where irradiation of the thoracic primary lesions can improve the patient's respiratory-related symptoms, reduce the tumor burden, improve the patient's quality of life, and prolong survival in some patients. Therefore, we propose that combination of immunotherapy and radiotherapy to the primary lesion for these patients, who are generally in good KPS status, may result in improved quality of life and prolonged survival. To date, there have been no clinical studies of immunotherapy combined with primary lesions radiation therapy in patients with advanced non-small cell lung cancer (driver gene-negative) after chemotherapy failure or recurrence, so we designed this prospective, randomized, controlled, investigator-initiated, phase II clinical study with the primary objective of evaluating the efficacy of combined immunotherapy and primary lesions radiation therapy in this patient population. This trial aims at investigating the feasibility and efficacy of this treatment strategy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Lung Neoplasms

Clinical Trial Details

NCT number	NCT04513301
Study type	Interventional
Source	Shanghai Cancer Hospital, China
Contact	Jiayan Chen, Master
Phone	86-18121299483
Email	chenjiayan2008@126.com
Status	Recruiting
Phase	Phase 2
Start date	January 1, 2020
Completion date	December 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03357094` - Pulmonary Ventilation/Perfusion Imaging for the Prediction of Postoperative Residual Pulmonary Function	N/A
Recruiting	`NCT05543954` - 68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients	Early Phase 1
Completed	`NCT01114958` - Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases	Phase 1
Recruiting	`NCT06004440` - Real World Registry for Use of the Ion Endoluminal System
Completed	`NCT02926768` - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors	Phase 1
Not yet recruiting	`NCT02907606` - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study	N/A
Active, not recruiting	`NCT02514512` - Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking	N/A
Completed	`NCT02334007` - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery	Phase 1/Phase 2
Completed	`NCT02531737` - Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With Lung Cancer	Phase 2
Active, not recruiting	`NCT02284633` - Blood Sample Monitoring of Patients With EGFR Mutated Lung Cancer
Completed	`NCT02106143` - RejuvenAir™ System Lobectomy Safety and Histology Study	N/A
Completed	`NCT01933789` - Improving Communication About Serious Illness	N/A
Enrolling by invitation	`NCT01687647` - Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure	Phase 3
Terminated	`NCT00356525` - Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor	Phase 2
Completed	`NCT00243685` - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis	Phase 2/Phase 3
Completed	`NCT00385177` - Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors	Phase 1
Completed	`NCT00351962` - Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours	N/A
Completed	`NCT00129844` - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer	Phase 2
Withdrawn	`NCT00090701` - A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer	Phase 2
Recruiting	`NCT01789229` - Establishment of a Tumor Bank for Tissue Samples

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.