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RecruitingLast updated: 15 March 2024

PRIME_LUNG: This study is assessing whether it is safe and feasible to administer radiation therapy to the lung before delivering standard of care systemic therapy (chemo-immunotherapy) for people with advanced non-small cell lung cancerPrimary Radiotherapy In MEtastatic Lung Cancer. A Pilot Study

Clinical summary

Summary

This study is recruiting people with newly diagnosed advanced (Stage IV) non-small cell lung cancer who have not received any prior treatment with systemic therapy. Eligible participants will be randomly allocated to either the Active Comparator Arm or the Experimental Arm.

In the Active Comparator Arm, participants will receive Standard of Care (SoC) systemic therapy. The drugs you will receive will depend on whether you have squamous cell or non-squamous cell non-small cell lung cancer.

For people with squamous cell, permitted SoC chemo-immunotherapy will include single agent immunotherapy (pembrolizumab) or in combination with chemotherapy (carboplatin or paclitaxel). Carbo/Paclitaxel/Pembrolizumab intravenous infusions are given every 3 weeks for cycles 1-4, followed by ongoing maintenance therapy with pembrolizumab alone from cycle 5.

For people with non-squamous cell, SoC chemo-immunotherapy will include single agent immunotherapy (pembrolizumab) or in combination with chemotherapy (Carboplatin or Pemetrexed). Carboplatin/Pemetrexed/Pembrolizumab infusions are given every 3 weeks for four cycles, followed by maintenance therapy with pemetrexed/pembrolizumab from Cycle 5.

In the Experimental Arm, participants will receive stereotactic ablative radiation therapy (SABR) to the lung, delivered before cycle one or cycle two of SoC chemo-immunotherapy. SoC chemo-immunotherapy in this group will be the same as in the Active Comparator group.

Conditions

This trial is treating patients with advanced non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I

Trial Acronym

PRIME_LUNG

More information

Trial Identifiers

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Trial sponsor

Test,Peter MacCallum Cancer Centre

Scientific Title

Primary Radiotherapy In MEtastatic Lung Cancer. A Pilot Study

Eligibility

Inclusion

  • 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
  • EGFR/ALK/ROS1 Wild-type
  • Primary disease suitable for radiotherapy and not requiring immediate palliative irradiation
  • ECOG 0-1

Exclusion

  • 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.
  • Has a history of (non-infectious) pneumonitis or current pneumonitis that requires active corticosteroids with a dose equivalent of prednisolone>10mg/d.
  • Has had any systemic anti-cancer therapy within 4 weeks prior to randomisation
  • A known diagnosis of idiopathic pulmonary fibrosis
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Uncontrolled brain metastases defined as not amenable to surgery or stereotactic radiotherapy

Inclusion

  • Your cancer has spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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