Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
Eligible patients will be enrolled into one of two sequential cohorts. In Cohort A, patients will receive an initial intravenous dose (100mg) of zirconium-89 labelled M7824 on Day 1. Sequential imaging will be performed over one week, to determine the biodistribution of 89Zr-M7824 into the tumour and normal tissues. All patients enrolled in Cohort 1, who remain on trial after Day 14, will receive a 1200mg dose of M7824 every two weeks, begining on Cycle 1 Day 15. Patients will receive another dose on Day 29 and on Day 43, every two weeks until disease progression or unacceptable toxicity. Patients who do not achieve complete remission in the Cohort after 3 doses of M7824 in Cycle 1 may commence treatment with concurrent carboplatin and pemetrexed chemotherapy at a conventional dose. Similar assessments will be undertaken in Cohort B; Cohort A will be used to determine whether or not high-PD-L1 positive disease is required upon entry to Cohort B.
Conditions
This trial is treating people with non-small cell lung cancer
Eligibility
Inclusion
- Adults (≥ 18 years) with histologically proven advanced NSCLC
- PD-L1 positive staining in > 1% of tumour cells in archival or fresh tissue (may be modified for Cohort B to require PDL1-high status and/or PD-L1 status to be tested on fresh tissue obtained a study entry, based on evaluation of data from Cohort A)
- Measurable disease by RECIST 1.1
- ECOG 0-1
- Expected survival more than 3 months
- Adequate organ function. Out of range values that are not clinically significant will be permitted, except for the following laboratory parameters, which must be within the ranges specified:
Hemoglobin ≥ 9 g/dL Neutrophils ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L INR ≤ 1.4 Serum creatinine ≤1.3 x ULN Estimated creatinine clearance ≥ 30 ml/min according to the Cockcroft Gault formula or local normal range Serum AST and ALT ≤2.5 x ULN Serum bilirubin ≤ 1.5 x ULN Available archived formalin-fixed paraffin embedded or frozen tumour tissue; or consents to tumour biopsy at enrolment (the latter is strongly preferred) Presence of a suitable reference tumour lesion for PET imaging i.e. measuring > 1.5cm and not located in the mediastinum
Exclusion
- Prior systemic immunotherapy for advanced NSCLC
- Patients who are unsuitable for chemotherapy in the investigator's judgement
- The participant's tumour harbors an EGFR sensitizing (activating) mutation, ALK translocation, ROS1 rearrangement, or BRAF V600E mutation
- Use of anti-cancer therapy including surgery, chemotherapy, immunotherapy, radiotherapy to a non-thoracic site or any investigational therapy within 28 days prior to Study Day 1
- Has received thoracic radiotherapy > 30 Gy within 6 months of the dose of study drug
- Previous malignant disease (other than NSCLC) within the last 3 years. Participants with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded. Participants with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Olivia Newton-John Cancer Research Institute
Scientific Title
A Bioimaging Study of 89Zr-M7824 PET Scans in Patients With Advanced or Metastatic NSCLC Receiving M7824 Alone or in Combination With Chemotherapy
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information