InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

CompletedLast updated: 11 April 2024

This phase I/II trial will use functional imaging (such as a PET scan) to evaluate the treatment response of non-small cell lung cancer patients receiving an immunotherapy drug (M7824) compared to non-small lung cancer patients receiving standard of care chemotherapyA Bioimaging Study of 89Zr-M7824 PET Scans in Patients With Advanced or Metastatic NSCLC Receiving M7824 Alone or in Combination With Chemotherapy

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 patients with non-small cell lung cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

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

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

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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • 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.

Participating hospitals

+ Show non-recruiting hospitals

Completed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

Submitting ... Please wait

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.