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Closed (no longer recruiting)Last updated: 1 May 2024

PACIFIC-4: This study is assessing how safe and effective immunotherapy plus radiation therapy is, compared to placebo and radiation therapy, in people with lymph-node negative non-small cell lung cancerA Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation

Clinical summary

Summary

The main part of this study is recruiting people with stage I/II lymph node negative (T1 to T3N0M0) non-small cell lung cancer who have not had prior therapy. This main study will randomly assign eligible participants to either the Experimental Arm or the Placebo Comparator Arm. In the Experimental Arm, participants will receive standard-of-care stereotactic body radiation therapy (SBRT) plus immunotherapy (durvalumab). SBRT will be delivered in 3, 4, 5 or 8 fractions. Durvalumab will be given at a dose of 1500mg every 4 weeks intravenously. In the Placebo Comparator Arm, participants will receive standard of care SBRT plus a placebo. SBRT will be delivered in 3, 4, 5 or 8 fractions. The Placebo will be given every 4 weeks via IV. In addition to this main study, an additional cohort will recruit participants with stage I/II lymph node-negative non-small cell lung cancer harbouring an EGFR mutation who have not had prior therapy. This cohort will receive standard of care SBRT followed by targeted therapy (osimertinib). SBRT will be delivered in 3, 4, 5 or 8 fractions. Osimertinib will be given at a dose of 80mg every day via oral tablet for up to 36 months.

Conditions

This trial is treating patients with lymph-node negative non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18 - 130

Phase

III

Trial Acronym

PACIFIC-4

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific Title

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation

Eligibility

Inclusion

Main Cohort Key Inclusion Criteria:

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. WHO/ECOG PS of 0, 1 or 2
  4. Life expectancy of at least 12 weeks
  5. Body weight >30 kg
  6. Submission of tumor tissue sample if available
  7. Adequate organ and marrow function required
  8. Patients with central or peripheral lesions are eligible
  9. Staging studies must be done during screening (PET-CT within 10 weeks)
  10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions

Osimertinib Cohort Key Inclusion Criteria

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. World Health Organization (WHO)/ECOG PS of 0, 1, or 2
  4. Patients with central or peripheral lesions are eligible
  5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
  6. Staging studies must be done during screening (PET-CT within 10 weeks)
  7. Submission of available tumor tissue sample
  8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
  9. Adequate bone marrow reserve or organ function required
  10. Female patients should be using highly effective contraceptive measures
  11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation

Exclusion

Main Cohort Key Exclusion Criteria:

  1. Mixed small cell and non-small cell cancer
  2. History of allogeneic organ transplantation
  3. History of another primary malignancy with exceptions
  4. History of active primary immunodeficiency
  5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
  6. Prior exposure to immune-mediated therapy with exceptions

Osimertinib Cohort Key Exclusion Criteria

  1. Mixed small cell and non-small cell cancer
  2. Patients currently receiving potent inducers of CYP3A4
  3. Patients with known or increased risk factor for QTc prolongation
  4. Treatment with any of the following:

    • Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
    • Prior treatment with neoadjuvant or adjuvant EGFR TKI
    • Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4
    • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
  5. Any of the following cardiac criteria

    • Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
    • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
    • Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

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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