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NCT02764086

INTENSE: A Phase I/II Study of INhomogeneous Targeted Dose Escalation in Non-Small CEll Lung Cancer

Terminated Phase 1, PHASE2 Last updated 13 April 2026
What this trial tests

Phase 1, PHASE2 trial testing Radiation in Non-Small Cell Lung Cancer in 6 participants. Terminated before completion.

Timeline
10 August 2016
Primary endpoint
5 June 2020
5 June 2020

Quick facts

Lead sponsorCancer Trials Ireland
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date10 August 2016
Primary completion5 June 2020
Estimated completion5 June 2020
Sites1 location across Ireland

Drugs / interventions tested

Conditions studied

Sponsor

Cancer Trials Ireland — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective non-randomised Phase I/II study with patients recruited to escalated dose cohorts. Escalated dose to the iGTV (internal gross tumour volume), with 60 Gy to the conventional PTV (planning target volume), will be delivered to successive cohorts of participants (6-12 participants/cohort) until the maximum tolerated oesophageal dose is determined. The minimum dose will be 60 Gy delivered via intensity modulated radiation therapy (IMRT) or volume modulated arc therapy (VMAT), planned on an Average Intensity Projection (AVIP) dataset. Standard of care chemotherapy. There will be two treatment arms; one with patients who are planned to receive neo-adjuvant or no chemotherapy, and the other with patients who are planned to receive concurrent chemotherapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Advanced radiation techniques for locally advanced non-small cell lung cancer: intensity-modulated radiation therapy and proton therapy.
    Yegya-Raman N, Zou W, Nie K, Malhotra J, et al · · 2018 · cited 24× · PMID 30206493 · DOI 10.21037/jtd.2018.07.29

Verify or expand the search:

Other trials of Radiation

Trials testing the same drug.

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

Other Cancer Trials Ireland trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02764086.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing