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PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study

ConditionNSCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter MacCallum Cancer Centre, Australia

About this trial

Outcome for patients diagnosed with advanced lung cancer remains poor; alternative treatment options are urgently needed. Studies in other metastatic cancers indicate radiotherapy to the primary tumour can improve outcomes. The investigators postulate this will also be observed in lung cancer patients. The aim of this pilot study is to assess the safety and feasibility of stereotactic ablative radiotherapy (SABR) to the lung primary prior to standard of care (SoC) systemic therapy in advanced non-small cell lung cancer (NSCLC). Forty patients with advanced (Stage IV) NSCLC will be recruited across the five Peter Mac campuses. Patients will be randomised to receive SoC systemic therapy with or without radiotherapy to the lung primary. Radiotherapy will be delivered before cycle 3 of SoC systemic therapy. Biospecimens will be collected for future translational research. The primary outcome of the study (feasibility of the protocol) will be assessed by the ability to deliver radiotherapy to the lung cancer primary, whilst meeting dose constraints. The study will also 1) evaluate proportion of patients who are willing to be randomised; 2) describe toxicity during the follow up period in each arm; 3) describe progression free survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have provided written informed consent for the trial.

Be ≥ 18 years of age on day of signing informed consent.

Newly diagnosed, metastatic (stage IV), non-small cell lung cancer (NSCLC), not amenable to curative surgery or curative radiotherapy

Histological or cytologically documented NSCLC

Disqualifiers

Medically unfit for systemic therapy

EGFR/ALK/ROS1 mutation positive

Has had previous thoracic radiotherapy of > 36Gy in 12 fractions (or equivalent) within the 6 months prior to randomisation.

Has diagnosed and/or treated additional malignancy within 3 years prior to randomisation with the exception of: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively treated early-stage cervical cancer, breast cancer or prostate cancer with no evidence of active disease. Other exceptions may be considered following consultation with the principal investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy

    Radiation

    35Gy/5# Central 40Gy/5# Large Tumours \>5cm (non-central) 36Gy/12# or 40Gy/15# Ultracentral lesions 50Gy/5# Peripheral Tumours ≤5cm

  • SoC systemic therapy

    Drug

    Permitted SoC chemoimmunotherapy for squamous patients will include single agent immunotherapy with Pembrolizumab or in combination with Carboplatin or Paclitaxel. Carbo/Paclitaxel/Pembro intravenous infusions are given every 3 weeks for cycle 1-4, followed by ongoing maintainence with Pembrolizumab from Cycle 5. For non-squamous patients, SoC chemoimmunotherapy will include single agent immunotherapy with Pembrolizumab or in combination with Carboplatin or Permetrexed. Carboplatin/Pemetrexed/Pembrolizumab infusions are given every 3 weeks for four cycles followed by maintenance with Pemetrexed/Pembrolizumab from Cycle 5.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Arm 1: SoC systemic therapyActive comparator 1 intervention
Group B: Arm 2: radiotherapy to lung primary, delivered before cycle three of SoC systemic therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

To assess the feasibility of the study design to be escalated without major modification directly to a randomised phase III design.

To assess the feasibility of the study design to be escalated without major modification directly to a randomised phase III design. Technical feasibility will be assessed by the ability to deliver radiotherapy to the lung cancer primary whilst meeting dose constraints tumour prior to cycle 3 of SoC systemic therapy in metastatic NSCLC. Radiotherapy to the primary in stage IV NSCLC will be considered worthwhile to be assessed in a large randomised study if radiotherapy is feasible in \>66% of patients randomised to the radiotherapy arm.

Time frame
18 months

Secondary outcomes

1

willingness to be randomised

evaluate the proportion of patients who are willing to be randomised after being approached for the study.

Time frame
18 months
2

safety of Radiotherapy addition using NCI CTCAE

The safety of the addition of radiotherapy by describing toxicity during the follow up period in each arm. Safety will be measured as adverse events (AE) and serious adverse events (SAEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

Time frame
24 months
3

PFS

The study will also describe progression free survival within 6 months of follow-up. PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the Investigator following principles of RECIST 1.1, or death from any cause, whichever occurs first.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peter MacCallum Cancer Centre, Australia

Lead sponsor

Source ClinicalTrials.gov
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