Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

Study summary

This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDurvalumab and Tremelimumab

Plus 14 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 14, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?16 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: AstraZeneca
Interventions being studied: Drug: Durvalumab; Drug: Tremelimumab; Drug: Cisplatin (dose level 4); Drug: Cisplatin (dose level 3); Drug: Carboplatin (dose level 1); Drug: Carboplatin (dose level 2); Drug: Etoposide (dose level 1); Drug: Etoposide (dose level 2); Drug: Paclitaxel; Drug: Pemetrexed; Radiation: External beam radiation (dose level 1); Radiation: External beam radiation (dose level 2); Radiation: External beam radiation (hyperfractionated); Drug: Cisplatin (dose level 1); Drug: Cisplatin (dose level 2); Radiation: External beam radiation (standard)

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

World Health Organization (WHO)/ECOG performance status of 0 or 1
Body weight \>30 kg at enrollment and treatment assignment
At least 1 measurable lesion, not previously irradiated
No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines)
For patients with oropharyngeal HNSCC HPV status has to be known

Reasons someone may not be able to joinExclusion criteria

Patients with simultaneous primary malignancies or bilateral tumors
Active or prior documented autoimmune or inflammatory disorders
Brain metastases or spinal cord compression
Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies)
Has a paraneoplastic syndrome (PNS) of autoimmune nature
HNSCC cohort: Head and neck cancer that does not include unresectable, locally advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown primary are also excluded
NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology
SCLC cohort: Extensive-stage SCLC

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Research SiteTucson, Arizona
Research SiteAurora, Colorado
Research SiteHouston, Texas
Research SiteKōtoku
Research SiteSunto-gun
Research SiteSeoul
Research SiteSeoul
Research SiteSeoul
Research SiteSeoul
Research SiteBadalona
Research SiteMadrid
Research SiteMálaga

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 14, 2025. Always confirm current availability with the study team.

View original record ↗