A phase II, open label, multiarm study to assess the efficay of new drugs in patients with Small Cell Lung Cancer whose cancer worsened during or after 90 days of platinum based chemotherapy

Phase 1

• Conditions: Patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistantdisease from prior platinum-based chemotherapy.; MedDRA version: 19.0Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001202-42-ES
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-21
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Histologically or cytologically documented extensive disease American Joint Committee on Cancer Stage IV SCLC (T any, N any, M1 a/b), including patients with:
•T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
•Biopsy-proven mixed SCLC and NSCLC histology
•Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
2.Patients must have demonstrated progressive disease (PD) either during first-line platinum-based chemotherapy (platinum refractory) or within 90 days of completing platinum-based chemotherapy (platinum resistant), and have not received further treatment apart from first-line platinum-based chemotherapy.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study results, including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from the study medications, or compromise the ability of the patient to give written informed consent.
2. Past medical history of interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified