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RecruitingLast updated: 28 February 2024

OCEANiC: This study is investigating whether certain tests that predict the likelihood of a cancer recurrence can determine whether people with EGFR-mutant non-small cell lung cancer can safely avoid chemotherapy after their cancer has been completely removed by surgeryA Phase II, Open-label, Multi-centre Clinical Trial on effect of Osimertinib, With or Without Adjuvant Chemotherapy, Guided by Tumour Next Generation Sequencing (NGS) Co-mutation Status and circulating tumour DNA (ctDNA) Detection on disease-free survival in Patients With Stage IIA-IIIA epidermal growth factor receptor (EGFR)-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection

Clinical summary

Summary

This study is recruiting people with non-small cell lung cancer with a mutation in epidermal growth factor receptor (known as EGFR mutation) who have had their tumour completely removed via surgery.

All eligible participants will undergo co-mutation NGS profiling (which looks for gene changes in cancer tissue) and circulating tumour DNA testing (which looks for fragments of the tumour moving through the blood stream). The NGS and ctDNA results will be used to determine if a participant's cancer is at higher or lower risk of returning.

Participants with a higher risk of their cancer returning will receive up to 4 cycles (over 12 weeks) of platinum doublet chemotherapy followed by up to three years of targeted therapy (with a drug called osimertinib, taken as a daily tablet).

Participants with a lower risk of their cancer returning will receive only targeted therapy (osimertinib) daily via oral tablet for up to three years. It is hoped that this study will help determine if targeted therapy alone may provide similar benefits with less toxicity, improved quality of life and reduced health care costs, to chemotherapy + targeted therapy.

Conditions

This trial is treating patients with non-small cell lung cancer who have had prior surgery

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

OCEANiC

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

AstraZeneca,University of Sydney,The Thoracic Oncology Group of Australasia (TOGA)

Scientific Title

A Phase II, Open-label, Multi-centre Clinical Trial on effect of Osimertinib, With or Without Adjuvant Chemotherapy, Guided by Tumour Next Generation Sequencing (NGS) Co-mutation Status and circulating tumour DNA (ctDNA) Detection on disease-free survival in Patients With Stage IIA-IIIA epidermal growth factor receptor (EGFR)-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection

Eligibility

Inclusion

1. Adults, aged 18 years or older, with histological diagnosis of NSCLC. Patients with mixed small cell lung cancer histology are not eligible.
2. Stage IIA to IIIA NSCLC according to AJCC 8th edition.
3. Complete surgical resection of the primary NSCLC is mandatory.
3.1. All gross tumour surgically removed at the end of surgery.
3.2. All surgical resection margins must be microscopically negative.
3.3. Resection may be accomplished by open or VATS techniques
3.4. Surgery may consist of lobectomy, sleeve resection, bi-lobectomy or pneumonectomy based on the intraoperative findings with appropriate lymph node sampling/mapping as determined by the surgeon. Patients who have only segmentectomies or wedge resections are not eligible.

4. Complete recovery from surgery at the time of registration. No more than 8 weeks may have elapsed between surgery and registration. Complete post-operative wound healing must have occurred following surgery.
5. Documented evidence of EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be sensitive to osimertinib. These include exon 19 deletions, L858R (exon 21), G719X (exon 18), L861Q (exon 21), S768I (exon 20) and T790M (exon 20). Compound mutations involving any of the listed sensitising mutations are allowed.
6. ECOG Performance Status of 0 or 1 within 14 days prior to planned treatment start date.
7. Tumour tissue available from diagnostic biopsy or surgical specimen for co-mutation testing.
8. Adequate organ system function within 14 days prior to planned treatment start date:
• Bone marrow function
i. Platelets more than or equal to 100 x 109/L
ii. Absolute neutrophil count (ANC) more than or equal to 1.5 x 109/L
iii. Haemoglobin more than or equal to 90 g/L
• Liver function
i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN)
ii. Total bilirubin less than or equal to 1.5 x ULN or 3 x ULN in the presence of documented Gilbert’s Syndrome (unconjugated hyperbilirubinaemia).
• Renal function
i. Measured creatinine clearance more than or equal to 45 mL/min (e.g. by 51Cr-EDTA or 99mTc-DTPA renography) or Calculated creatinine clearance more than or equal to 45 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.

9. MRI scan of the brain must be performed at any time between diagnosis and registration.
10. Baseline ECG with QTc <470ms and no clinically significant arrhythmias.
11. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
12. Signed, written informed consent.

Exclusion

1. Previous diagnosis of another lung cancer within 5 years prior to registration.
2. Prior systemic treatment for NSCLC including prior EGFR pathway inhibitor treatment.
3. History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
4. Post-operative radiotherapy (PORT) planned.
5. Prior radiation to lung and/or mediastinum.
6. Known history of interstitial lung disease (ILD) or drug-induced pneumonitis requiring steroid treatment, or any evidence of clinically active ILD.
7. Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.
8. Significant history of cardiovascular disease. Any clinically important abnormalities in rhythm conduction or morphology of resting ECG e.g. Complete left bundle branch block, third degree heart block and second degree heart block. Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities, Congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes.
9. Significant history of peripheral vascular or cerebrovascular disease.
10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active hepatitis B, hepatitis C, or HIV. Chronic hepatitis B carrier with undetectable hepatitis DNA level is allowed. Serological testing is not mandatory unless clinically indicated.
11. 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.
12. History of another concurrent active malignancy that requires ongoing treatment.
13. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
14. Treatment with prohibited medications which may interact with study treatment.
15. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
16. Pregnancy, lactation, or inadequate contraception. Participants must be post-menopausal, infertile, or use a reliable means of contraception. Participants of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Participants who are having a sexual relationship in which their partner could become pregnant must have been surgically sterilised or use a (double if required) barrier method of contraception.
17. Involvement in the planning and/or conduct of the study (applies to both NHMRC CTC staff and/or staff at the study site).

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.

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.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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

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