IMPT Dose Escalation for NSCLC (HyDose)

Trial Title: IMPT Dose Escalation for NSCLC (HyDose)

NCT ID: NCT06484491

Condition: Carcinoma, Non-Small-Cell Lung

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Cisplatin
Carboplatin
Docetaxel
Pemetrexed
Durvalumab

Conditions: Keywords:
Lung Neoplasms
Proton Therapy
Radiotherapy

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Standard-dose intensity-modulated proton therapy (IMPT-60)
Description: The standard care group will receive 60.0 Gy (RBE) to the whole clinical target volume
Arm group label: Arm 1 Standard care

Intervention type: Radiation
Intervention name: Dose-escalated intensity-modulated proton therapy (IMPT-74)
Description: Heterogeneous simultaneous integrated boost of 74.0 Gy (RBE) to primary tumor >15mm away form mediastinal envelope, and 64.0 Gy (RBE) to primary tumor =< 15mm away from mediastinal envelope. The rest of the clinical target volume, including affected lymph nodes, receives 60.0 Gy (RBE).
Arm group label: Arm 2 Intervention group

Intervention type: Drug
Intervention name: Cisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy
Description: Induction course: -Cisplatin (75 mg/m2) or carboplatin (AUC 6) + pemetrexed (500mg/m2). Concurrent chemoradiotherapy: - Weekly cisplatin (20mg/m2) + docetaxel (20mg/m2) on Mondays. - Radiotherapy will be given for 5x5 days.
Arm group label: Arm 1 Standard care
Arm group label: Arm 2 Intervention group

Intervention type: Drug
Intervention name: Immunotherapy: adjuvant durvalumab
Description: Adjuvant treatment will be given starting 1-6 weeks after chemoradiotherapy if no progression, good performance (PS 0-1), no other contra-indication for immunotherapy. Doses: - Start durvalumab 10 mg/kg 1x/14 days. - If possible after 2 courses switch to 1500 mg flat dose 1x/4 wk. - Continue for 12 months in total.
Arm group label: Arm 1 Standard care
Arm group label: Arm 2 Intervention group

Summary: In this randomized controlled trial, the aim is to test the hypothesis that proton therapy dose escalation using a heterogeneous simultaneous boost on the primary tumor as part of chemoradiotherapy for locally advanced non-small-cell lung cancer is safe, i.e. does not result in an increase in severe toxicity compared to standard-dose proton therapy. Secondarily, the goal is to estimate the treatment effect size, if any. In the intervention group, patients will receive intensity-modulated proton therapy dose escalation to the primary tumor up to 74.0 Gy or 64.0 Gy (RBE of 1.1) in 25 fractions, depending on proximity to the mediastinal envelope. In the control group, patients will receive 60.0 Gy intensity-modulated proton therapy in 25 fractions.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically proven stage III NSCLC - Planned for CCRT and adjuvant immunotherapy (intention to treat) - Primary tumour volume outside of mediastinal PRV (i.e., mediastinal envelope + 5 mm) ≥60% of total primary tumour volume (true for 75% of patients in preliminary analysis), for sufficient dose escalation Exclusion Criteria: - Chemotherapy not given concurrently with radiotherapy - Upfront decision that adjuvant immunotherapy is not possible - Primary tumour overlapping ≥40% with mediastinal PRV

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UMCG

Address:
City: Groningen
Country: Netherlands

Start date: October 1, 2024

Completion date: January 1, 2027

Lead sponsor:
Agency: University Medical Center Groningen
Agency class: Other

Collaborator:
Agency: Dutch Cancer Society
Agency class: Other

Source: University Medical Center Groningen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06484491