First line Immunotherapy-chemotherapy versus Immunotherapy-chemotherapy Combined With Stereotactic Body Radiation for Metastatic NSCLC patients: A Phase II Randomized, Open Label Clinical Trial. - ICSMEN-Trial

AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA0 sites132 target enrollmentOctober 12, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with both squamous and nonsquamous metastatic non-small cell lung cancer (NSCLC) wild type in EGFR, KRAS, ALK and ROS1.
Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
Enrollment: 132
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

October 12, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA

•\- Histologic confirmation of NSCLC by biopsy or cytology (primary cancer are eligible: squamous cell carcinoma, adenocarcinoma; no sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene translocation; stage IV according to the 8th version of the IASLC system);
•\- Age \>\= 18 years;
•\- Eastern Cooperative Oncology Group (ECOG) performance status score of 0\-1;
•\- At least two lesions measurable according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1\.1;
•\- Life expectancy of at least 3 months;
•\- Signature of informed consent form;
•\- Patients must have adequate organ function.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•\- Eastern Cooperative Oncology Group (ECOG) performance status score \>2;
•\- Patients scheduled to receive other concomitant local therapy (including standard fractionated radiation therapy and surgery) during this protocol, except at disease progression;
•\- Mandatory detention for treatment of a psychiatric or physical illness;
•\- Pregnancy or lactating (because treatment carries unpredictable risks to the embryo or fetus);
•\- Previous immunotherapy with PD1 or CTLA4 antibodies;
•\- Known or suspected active autoimmune disease;
•\- History of antibodies to human immunodeficiency virus (HIV) \-1 or \-2;
•\- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection;
•\- Patients who are unable to receive chemotherapy;
•\- Conditions requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days of study drug administration;