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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT04051827

NCT04051827
Completed Phase 1 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with non-small cell lung cancer (NSCLC) that is locally advanced, has come back, or has spread to other parts of the body (Stage IV), and surgery or radiation as a main treatment is not an option for you.
  • Your cancer has stopped responding to, or you could not tolerate, the standard treatments available to you.
  • You are generally able to carry out light activity and care for yourself (your doctor will assess this using a standard scale).
  • Your doctors expect you to live for at least 3 more months.
  • Your liver is working well enough, based on specific blood test results (confirm with trial site).
  • Your kidneys are working well enough, based on a specific blood test result (confirm with trial site).
  • Your blood protein (albumin) levels and pancreas enzyme levels are within an acceptable range (confirm with trial site).
  • Your bone marrow is producing enough blood cells, including white blood cells, platelets, and red blood cells, shown by blood tests (confirm with trial site).
  • Your heart's electrical activity is within a normal range, shown by a heart tracing (ECG) test.
  • Any side effects from previous cancer treatments have mostly cleared up before starting this trial.
  • You have suitable veins for blood samples to be taken during the study.

Who may not be able to join:

  • You have taken certain medications that strongly affect how the body processes drugs (CYP3A inhibitors or inducers) within the last 2 weeks (confirm with trial site).
  • You have received other small-molecule cancer treatments or experimental drugs within the last 2 weeks.
  • You have received certain cancer-fighting antibody treatments (such as immunotherapy checkpoint inhibitors) within the last 28 days.
  • You have had radiotherapy within the last 14 days, with some exceptions for certain targeted or palliative radiation types given more than 7 days ago (confirm with trial site).
  • You have had major surgery within the last 28 days (minor procedures like biopsies are generally acceptable).
  • You have been diagnosed with another type of cancer, unless it was certain limited types that have been fully treated (such as some skin cancers, cervical cancer in situ, prostate cancer, or another cancer you have been free of for at least 3 years).
  • You have active or growing tumours in your brain that are untreated or getting worse (stable, previously treated brain tumours that do not require steroid medication may be acceptable — confirm with trial site).
  • You currently have cancer pressing on your spinal cord or cancer spread to the lining around the brain or spinal cord.
  • You have high blood pressure that is not being controlled with treatment.
  • You have had a serious heart condition in the past 6 months, such as a heart attack, heart failure, unstable chest pain, a stroke, or certain heart rhythm problems.
  • You are taking medications known to cause a specific dangerous heart rhythm problem called torsades de pointes (confirm with trial site).
  • You have a stomach or bowel condition that might stop you from properly absorbing the trial medication taken by mouth.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Millennium Pharmaceuticals, Inc.
Registry
clinicaltrials_gov
Start date
23 December 2019
Est. completion
17 December 2020

Where this trial is recruiting

🇦🇺 Australia 🇳🇱 Netherlands 🇸🇬 Singapore

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part A, Cmax: Geometric Mean Maximum Observed Plasma Concentration (Cmax) for Midazolam Administered Orally With Mobocertinib (Cycle 1 Day 24) and Without Mobocertinib (Cycle 1 Day 1); Part A, AUC∞: Geometric Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam Administered Orally With Mobocertinib (Cycle 1 Day 24) and Without Mobocertinib (Cycle 1 Day 1); Part A, Cmax: Geometric Mean Maximum Observed Plasma Concentration (Cmax) for Midazolam Administered Intravenously With Mobocertinib (Cycle 1 Day 25) and Without Mobocertinib (Cycle 1 Day 2); Part A, AUC∞...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov