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Primary Radiotherapy In MEtastatic Lung Cancer

ConditionCarcinoma, Non-Small-Cell Lung (NSCLC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrans Tasman Radiation Oncology Group

About this trial

Lung cancer has the highest mortality rate of all cancers in Australia and is an area of unmet need. It starts in the lung (the primary tumour), and then spreads (metastasise) to other organs. The PRIME-Lung clinical trial will investigate if radiotherapy to the primary lung tumour, in addition to standard drug therapies, for patients with metastatic lung cancer will lead to less spread of cancer, prolong life, improve patient well-being and be cost-effective for the health care system.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed metastatic (stage IV) NSCLC, not amenable to curative surgery or curative radiotherapy

Histologically or cytologically documented NSCLC

Primary suitable for radiotherapy and not requiring immediate palliative thoracic irradiation

Investigator deemed appropriate for SoC systemic therapy

Disqualifiers

Medically unfit for systemic therapy

EGFR/ALK/ROS1 mutation positive or actionable driver mutation with intention to use available targeted drug therapy

Has had previous thoracic radiotherapy of > 36Gy within the 6 months prior to randomisation.

Has been diagnosed and/or treated additional malignancy within 2 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 and not on active therapy. Other exceptions may be considered following consultation with the principal investigator

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy followed by chemotherapy

    Combination product

    Standard of care (SoC) regimens available on the Australian PBS or relevant practice framework (Ireland and Canada) as per usual standard clinical practice are allowable in this protocol as SoC regimens. Radiotherapy Techniques: * Highly conformal techniques (IMRT/VMAT) * High-precision techniques are allowed for non-centrally located primaries Radiotherapy Dose: \- Several fractionation schedules allowed; minimum biological effective dose approximating 50Gy (α/β ratio = 10); 50Gy in 20 fractions, 40Gy in 15 fractions, and 35Gy in 5 fractions

  • Standard of Care (SOC)

    Drug

    Standard of care (SoC) regimens available on the Australian PBS or relevant practice framework (Ireland and Canada) as per usual standard clinical practice are allowable in this protocol as SoC regimens.

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Arm1: Standard of CareActive comparator 1 intervention
Group B: Arm 2: Standard of Care + Radiotherapy to primaryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

To assess the overall survival of patients receiving SoC systemic therapy with or without radiotherapy to the primary lung tumour

Time frame
5 years after the last participant was recruited

Secondary outcomes

1

Thoracic toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

To assess the safety of the addition of radiotherapy by describing thoracic toxicities of interest during the follow up period in each arm (as assessed by NCI CTCAE v5.0) and to describe the discontinuation rate of systemic therapy and reasons for discontinuation

Time frame
2-years after the last participant has been randomised
2

Progression Free Survival

To assess the likelihood of progression, or death, in each arm

Time frame
2-years after the last participant has been randomised
3

Cancer specific survival

To assess death from cancer-related causes in each arm

Time frame
2-years after the last participant has been randomised
4

Patient Reported Quality of Life (QoL) assessed using EORTC QLQ-C30 questionnaire

To compare the effect of treatment on overall QOL, at each time point (baseline, 3, 6, 12, and 24 months) between trial arms, collected on European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) questionnaire.

Time frame
2-years after the last participant has been randomised

Other outcomes

Sponsors and contacts

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

Trans Tasman Radiation Oncology Group

Lead sponsor

Thoracic Oncology Group of Australasia (TOGA)

Collaborator

Source ClinicalTrials.gov
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