IMPT Dose Escalation for NSCLC (HyDose)

University Medical Center Groningen (UMCG)

Status: Not yet enrolling

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Radiation: Dose-escalated intensity-modulated proton therapy (IMPT-74); Radiation: Standard-dose intensity-modulated proton therapy (IMPT-60); Drug: Immunotherapy: adjuvant durvalumab; Drug: Cisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06484491

PNM16745

NL86435.042.24 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Arm 1 Standard care

Active Comparator group

Description:

Standard dose of IMPT

Treatment:

Drug: Cisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy

Drug: Immunotherapy: adjuvant durvalumab

Radiation: Standard-dose intensity-modulated proton therapy (IMPT-60)

Arm 2 Intervention group

Experimental group

Description:

Dose-escalated IMPT

Treatment:

Drug: Cisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy

Drug: Immunotherapy: adjuvant durvalumab

Radiation: Dose-escalated intensity-modulated proton therapy (IMPT-74)