Stereotactic Body Radiation in combination with immunotherapy-chemotherapy in patients with Metastatic Non-Small Cell Lung Cancer.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002453-28-IT

Enrollment

132

Registered

2021-10-12

Start date

2021-08-23

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with both squamous and nonsquamous metastatic non-small cell lung cancer (NSCLC) wild type in EGFR, KRAS, ALK and ROS1. MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Pemetrexed Product Code: [NA] Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: PEMETREXED DISODICO CAS Number: 137281-23-3 Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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: 1) Safety 2) PFS (progression-free survival) 3) OS (overall survival) 4) TTF (duration of response to treatment) 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	—

Measure

Time frame

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: 1) Safety 2) PFS (progression-free survival) 3) OS (overall survival) 4) TTF (duration of response to treatment) 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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Contacts

Public ContactInfrastruttura ricerca e statistica

Azienda USL IRCCS di Reggio Emilia

massimo.costantini@ausl.re.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026