Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

Phase 1

Active, not recruiting

• Conditions: Carcinoma, Squamous Cell of Head and Neck; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

• Registration Number: NCT03509012
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-3-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

<br><br> - World Health Organization (WHO)/ECOG performance status of 0 or 1<br><br> - Body weight >30 kg at enrollment and treatment assignment<br><br> - At least 1 measurable lesion, not previously irradiated<br><br> - No prior exposure to immune-mediated therapy (including therapeutic anticancer<br> vaccines)<br><br> - For patients with oropharyngeal HNSCC HPV status has to be known<br><br>Exclusion criteria:<br><br> - Patients with simultaneous primary malignancies or bilateral tumors<br><br> - Active or prior documented autoimmune or inflammatory disorders<br><br> - Brain metastases or spinal cord compression<br><br> - Active infection including tuberculosis, hepatitis B, hepatitis C, or human<br> immunodeficiency virus (HIV; positive HIV 1/2 antibodies)<br><br> - Has a paraneoplastic syndrome (PNS) of autoimmune nature<br><br> - HNSCC cohort: Head and neck cancer that does not include unresectable, locally<br> advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown<br> primary are also excluded<br><br> - NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology<br><br> - SCLC cohort: Extensive-stage SCLC

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects with Dose Limiting Toxicities (DLTs);Number of subjects with Adverse Events (AEs)

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS);Progression-free survival (PFS);Overall Survival (OS);Objective response rate (ORR);Best objective response (BoR);Duration of response (DoR);Disease control rate (DCR)