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

ATOMIC: This phase II/III trial is testing a new drug (ADI-PEG 20) in combination with standard chemotherapy for patients with pleural mesotheliomaRandomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesothelioma With Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

Clinical summary

Summary

Eligible patients will be randomised to receive 36 mg/m2 of weekly ADI-PEG 20 or a placebo, in combination with pemetrexed (500mg/m2) and cisplatin (75mg/m2) which will be administered intravenously every three weeks.

Conditions

This trial is treating patients with mesothelioma.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II/III

Trial Acronym

ATOMIC

More information

Trial Identifiers

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Trial sponsor

Polaris Group

Scientific Title

Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesothelioma With Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

Eligibility

Inclusion

  • Histologically proven unresectable MPM of biphasic or sarcomatoid histology
  • Naïve to chemotherapy or immunotherapy
  • ECOG PS 0-1
  • Expected survival of at least 3 months
  • Age 18 years or over (there is no upper age limit)
  • Measurable disease by modified RECIST criteria for MPM for local pleural disease and RECIST 1.1 criteria for metastatic lesions
  • Written (signed and dated) informed consent and must be capable of co-operating with treatment and follow up
  • Adequate hematologic, hepatic, and renal function

Exclusion

  • Radiotherapy (except for palliative reasons) in the previous two weeks before study treatment
  • History of unstable cardiac disease
  • Ongoing toxic manifestations of previous treatments
  • Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery)
  • Major thoracic or abdominal surgery from which the patient has not yet recovered.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • 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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