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Study to Assess Safety,Tolerability,Efficacy of PM01183 and Atezolizumab in Patients w/ Advanced Small Cell Lung Cancer.

NCT04253145 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2023-11-18

No results posted yet for this study

Summary

Prospective, open-label, uncontrolled and multicenter phase I-II study in SCLC patients with ECOG PS 0-1 who have failed one prior platinum-containing line but no more than one chemotherapy-containing line. The study will be divided into two parts: a dose-ranging phase I with escalating doses of PM01183 in combination with a fixed dose of atezolizumab, followed by a single-arm phase II part with expansion at the RD determined during the phase I.

Conditions

  • Carcinoma, Small Cell Lung

Interventions

DRUG

PM 01183

Lyophilisate for solution for infusion

DRUG

Atezolizumab

Concentrate for solution for infusion

Sponsors & Collaborators

  • Fundacion Oncosur

    lead NETWORK

Principal Investigators

  • Santiago Ponce, MD · Hospital 12 de Octubre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253145 on ClinicalTrials.gov