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Moderately Hypofractionated Chemoradiation and Immunotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (MODERN-LUNG)

Phase 2 Study of a Moderately Hypofractionated Schedule of Chemoradiation followed by Immunotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001198910
Acronym
MODERN-LUNG
Enrollment
50
Registered
2020-11-10
Start date
2021-04-15
Completion date
2025-11-13
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine if larger doses of radiation given over a shorter period of time, as compared to standard radiation therapy, given with chemotherapy and followed by immunotherapy is safe for participants. Who is it for? You may be eligible for this study if you are an adult with non-small cell lung cancer. Study details All participants will receive radiation daily with chemotherapy weekly for 4 weeks. They will then receive immunotherapy either fortnightly or monthly for up to 12 months. It is hoped that this study will then determine if further research into this treatment method is necessary.

Interventions

All participants will receive radiotherapy with chemotherapy followed by maintenance immunotherapy. Radiotherapy will be delivered to a total dose of 55 Gray (Gy) in 20 fractions at 2.75 Gy per fraction daily, 5 days per week over 4 weeks. Chemotherapy will be delivered intravenously weekly for 4 weeks consisting of Paclitaxel (45mg/m2) and carboplatin (2AUC). Other platinum doublets allowable at the discretion of medical oncologists after discussion with Principal Investigator. Maintenance im

All participants will receive radiotherapy with chemotherapy followed by maintenance immunotherapy. Radiotherapy will be delivered to a total dose of 55 Gray (Gy) in 20 fractions at 2.75 Gy per fraction daily, 5 days per week over 4 weeks. Chemotherapy will be delivered intravenously weekly for 4 weeks consisting of Paclitaxel (45mg/m2) and carboplatin (2AUC). Other platinum doublets allowable at the discretion of medical oncologists after discussion with Principal Investigator. Maintenance immunotherapy consists of Durvalumab either 10mg/kg in 26 x 14-day cycles or 1500mg in 13 x 28-day cycles to the maximum number of cycles or until disease progression or unacceptable toxicity. Treatment details will be captured within the electronic case record forms.

Sponsors

Calvary Mater Newcastle
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Unresectable locally advanced Non-small cell lung carcinoma Considered suitable to receive chemoradiation and immunotherapy ECOG performance status 0-2

Exclusion criteria

Unable to meet radiotherapy planning constraints Previous thoracic radiotherapy Life expectancy less than 3 years Received induction chemotherapy prior to chemoradiotherapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026