EUCTR2017-001664-37-IT
Active, Not Recruiting
Phase 1
A randomized phase 2 study comparing immunotherapy with chemotherapy in the treatment of elderly patients with advanced NSCLC - MILES 5
Conditionspatients with advanced NSCLCMedDRA version: 20.0Level: LLTClassification code 10001160Term: Adenocarcinoma lungSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsCARBOPLATINO SANDOZ GMBH - 10MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 60MLGEMCITABINA ACCORD - 100 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 15 MLALIMTA - 100 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO(VETRO) 1 FLACONCINO
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- patients with advanced NSCLC
- Sponsor
- ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
- Enrollment
- 240
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female ³ 70 years of age.
- •Histological documentation of primary squamous or non squamous non\-small cell lung carcinoma.
- •Stage IV or IIIC disease with supraclavear metastatic nodes (according to TNM 8th edition).
- •PD\-L1 expression in tumor cells (TC) \= 25%\* or unknown due to lack of tumor specimen (no more than 25% of the overall sample size will be allowed)
- •Clinical or radiologic evidence of disease (at least one measurable or non measurable lesion).
- •ECOG performance status 0 to 1\.
- •Life expectancy \> 3 months.
- •Adequate renal and hepatic function, defined as:
- •Total serum bilirubin \= 1\.5 institutional ULN.
- •AST and/or ALT \= 2\.5 x ULN for the institution (or \= 5 x ULN if liver metastases are present)
Exclusion Criteria
- •Cancer related
- •1\.Activating epidermal growth factor receptor mutation (exon19 deletion or exon 21 L858R mutation or other activating/sensitizing mutations).
- •2\.ALK or ROS1 positive (immunohistochemistry or FISH)
- •3\.Mixed small\-cell lung cancer and NSCLC histology.
- •Prior, current or planned treatment related
- •4\.Prior chemotherapy or any other medical treatment for advanced NSCLC (previous neoadjuvant or adjuvant chemotherapy is allowed if \> 6 months previously).
- •5\.Prior exposure to immunomodulatory therapy, including, but not limited to, other anti\-programmed cell death1 (PD\-1\), anti\-programmed cell death ligand 1 (PD\-L1\), or anti PD\-L2 antibodies.
- •6\.Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment ( corticosteroids at physiological doses not exceeding 10 mg/day of prednisone or an equivalent corticosteroid are allowed).
- •7\.Any concurrent investigational product or other anticancer treatment.
- •Prior or concomitant conditions or procedures related
Outcomes
Primary Outcomes
Not specified
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