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Moderately Hypofractionated Radiotherapy versus Conventional Fractionated Radiotherapy for Concurrent Chemoradiotherapy Plus Consolidation Immunotherapy for Unresectble Driver Mutation-Negative Stage III Non-Small Cell Lung Cancer: A Randomized Controlled Phase 3 Clinical Trial (DISCOVER-2)

Moderately Hypofractionated Radiotherapy versus Conventional Fractionated Radiotherapy for Concurrent Chemoradiotherapy Plus Consolidation Immunotherapy for Unresectble Driver Mutation-Negative Stage III Non-Small Cell Lung Cancer: A Randomized Controlled Phase 3 Clinical Trial (DISCOVER-2)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080122
Enrollment
Unknown
Registered
2024-01-22
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Lung Cancer

Interventions

Hypofractionated group:Hypofractionated radiotherapy will be given 5 times a week (Monday to Friday) and 4 weeks with a total dose of 60Gy/20Fx/4W at 3 GY/20 fractions by intensity-modulated radiation
Conventional fractionated group:Conventional fractionated radiotherapy will be given 5 times a week (Monday to Friday) and 6 weeks with a total dose of 60Gy/30Fx/6w at 2 GY/30 fractions by intensity-m

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ? NSCLC confirmed by pathological diagnosis; ? Clinical stage III (AJCC/UICCTNM stage 8th) diagnosed by CT, MRI and PET-CT; ?Inoperable: must be consulted by two senior thoracic surgeons in the same center. If the two doctors have different opinions, the third senior thoracic surgeon should be consulted. ? Age =18 years; ? PS 0-1; ? The patients had not received any other anti-tumor treatment before the initial treatment, and had no pleural invasion, pleural effusion, respiratory insufficiency or pathological changes of heart, liver or kidney; ? Negative driver genes mutation in the biopsy samples of adenocarcinoma patients, including EGFR-sensitive mutations (del in exon 19, L858R mutation in exon 21), ALK rearrangement, ROS1 fusion and RET fusion; ? No history of chest radiotherapy; ? Patients who can understand the situation of this study and have signed the informed consent.

Exclusion criteria

Exclusion criteria: ? Patients with other malignant tumors simultaneously or with malignant tumor in other organs and tumor-free survival time 1.5 times the upper limit of normal (ULN); L-Aspartic Acid aminotransferase (AST) and Alanine transaminase (Alt) > 2.5 times the ULN; serum creatinine > 1.5 times the upper limit of normal level and the creatinine clearance rate was less than 60 ml/min; ?Lack of or having limited legal capacity; ?Use of other experimental drugs or participation in other clinical trials; ? Any other condition that the researchers considered unsuitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
overall survival;progression free survival;

Secondary

MeasureTime frame
time to progression, TTP;objective response rate, ORR;duration of response,DoR;toxicity;

Countries

China

Contacts

Public ContactHe Jian

Zhongshan Hospital, Fudan University

hejian62@163.com+86 133 8605 7161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026