Phase 2 Lung Cancer Trial, Recruiting NCT05450965 Sponsor: University of Maryland, Baltimore Condition: Lung Cancer
Back to Lung Cancer

Phase 2 Lung Cancer Trial, Recruiting

NCT05450965
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with small cell lung cancer, confirmed by a lab test (biopsy or cell sample).
  • You have at least one tumor that can be measured on a scan (meeting specific size requirements).
  • Your cancer has come back or stopped responding to standard platinum-based chemotherapy, and you have received no more than two rounds of chemotherapy overall for advanced-stage disease (with some exceptions for earlier treatment — confirm with trial site).
  • You are 18 years of age or older.
  • You are able to swallow and take oral (by mouth) medication.
  • You are reasonably well and able to carry out daily activities (a doctor will assess this using a standard scale).
  • Your liver, kidneys, and bone marrow are functioning well enough as confirmed by blood tests.
  • If you could become pregnant, you have had a negative pregnancy test within 48 hours before starting the study treatment.
  • You and your partner agree to use reliable contraception during the trial if there is any chance of pregnancy.
  • You are willing and able to read and sign a consent form agreeing to take part.
  • People of all genders, races, and ethnic backgrounds are welcome to apply.

Who may not be able to join:

  • You have received chemotherapy within the last 4 weeks (or 6 weeks for certain specific drugs), radiation therapy or biological treatments within the last 2 weeks, or you still have significant side effects from earlier treatments.
  • You are currently taking part in another clinical trial or receiving another experimental treatment.
  • You have brain metastases (cancer that has spread to the brain) that are not stable or are causing symptoms — those with previously treated and stable brain metastases may still be eligible, but must be on a low or stable dose of steroids (confirm with trial site).
  • You have an active digestive condition that might stop you from properly absorbing oral medication.
  • You have had a serious allergic reaction to drugs similar to the study drug (onvansertib).
  • You have an uncontrolled serious illness, such as an active infection, heart failure, unstable chest pain, irregular heartbeat, or a mental health or personal situation that would make it difficult to follow the study requirements.
  • You have untreated or active Hepatitis B, Hepatitis C, or HIV — although patients with HIV who have had a stable, effective treatment for at least six months and an undetectable viral load may be considered with sponsor approval.
  • You are currently using or have used certain bone marrow-stimulating medications (such as G-CSF or GM-CSF) within the 2 weeks before starting the study drug.
  • You have had major surgery within the 2 weeks before starting the study drug, or you have not yet fully recovered from a recent surgery.
  • You are unwilling or unable to follow the study plan or work cooperatively with the research team.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
19 July 2022
Est. completion
31 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective Response Rate (ORR)

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: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov