Stereotactic Body Radiation in combination with immunotherapy-chemotherapy in patients with Metastatic Non-Small Cell Lung Cancer.
- Conditions
- Patients with both squamous and nonsquamous metastatic non-small cell lung cancer (NSCLC) wild type in EGFR, KRAS, ALK and ROS1.MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002453-28-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 132
- 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
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
- 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;
- Allergies or adverse drug reactions;
- Contraindications to radiation therapy;
- History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate whether the ORR (Objective Response Rate) assessed at 14 weeks after the start of treatment is higher in the experimental group than in the control group.;Secondary Objective: Secondary objectives are to compare the two treatment arms in terms of:<br>1) Safety<br>2) PFS (progression-free survival)<br>3) OS (overall survival)<br>4) TTF (duration of response to treatment)<br>5) Quality of life;Primary end point(s): Tumor response rate will be measured by iRECIST criteria. The response categories will be complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). Overall response rate (ORR) will be defined as the proportion of subjects with the best overall response of CR or PR. The ORR will be calculated with both confirmed and unconfirmed responses as responses.;Timepoint(s) of evaluation of this end point: This endpoint will be measured at 14 weeks after the start of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Quality of life; Safety; TTF (Treatment response duration); PFS (progression free survival); Overall survival (OS);Timepoint(s) of evaluation of this end point: It will be measured with validated questionnaires (EORTC QLQC30 & QLQ-LC13) administered at baseline, at the end of treatment and at each administration of pembrolizumab.; From start treatment since 4 weeks after the last dose of platinum-chemioteraphy; Time to Treatment Failure (TTF) will be measured as time between randomization and treatment failure defined as first date of documented progression, based on investigator assessment (as per iRECIST criteria).; Progression Free survival (PFS) will be measured from the date of randomization to the date of first documented disease progression or the date of death due to any cause.; It will be calculated as the time (days) from the date of randomization to death from any cause. Survival for subjects who will be alive or lost to follow-up at or