At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 18 enrolled

Drug / intervention

Concurrent chemotherapy +2 moredrug

Likely dose

Concurrent chemotherapy 25mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04951063

NCT04951063Phase 1Completed

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Fraction Dose Escalation of Hypofractionated Radiotherapy With Concurrent Chemotherapy and Subsequent Consolidation Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: a Phase 1 Study

Sun Yat-sen University·interventional·Posted Jul 6, 2021·Updated Dec 15, 2023

In Brief

A Phase 1 clinical trial evaluating Hypofractionated radiotherapy, Concurrent chemotherapy, and 1 other intervention for Locally Advanced Lung Carcinoma. Completed, enrolled 18 participants across 1 site.

Detailed Summary

This Phase 1 trial aimed to determine the maximum tolerated fraction dose (MTD) of hypofractionated radiotherapy (hypo-RT) combined with concurrent chemotherapy and subsequent consolidation immune checkpoint inhibitors (cICI) for patients with locally advanced non-small cell lung cancer (LA-NSCLC).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLocally Advanced Lung Carcinoma

CountriesChina

Collaborators--

Timeline

Phase 1CompletedFinished

20222023202420252026

Enrollment StartJun 2021

First PostedJul 2021

Primary CompletionMar 2023

Study CompletionSep 2023

TodayJul 2026

First PostedJul 6, 2021

Enrollment StartJun 1, 2021

Primary CompletionMar 31, 2023

Study CompletionSep 30, 2023

TodayJul 1, 2026

Enrollment to primary: 1.8 yearsPosted 5.0 years ago

Interventions

Hypofractionated radiotherapyradiation

Split-course adaptive HRT-CHT is administered at the following three dose levels: 1. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course; 2. Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course; 3. Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course， DT 3000cGy/6 daily fractions/500cGy in the second course.

Concurrent chemotherapydrug

weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT

Consolidation immunotherapydrug

Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.