Study on ADI-PEG 20 with Gemcitabine and Docetaxel for Lung Cancer After Initial Treatment Stops Working

Inclusion Criteria

• Have a confirmed diagnosis of extensive stage small cell or metastatic non-small cell lung cancer that has worsened after initial treatment.
• Be considered fit for treatment with gemcitabine and docetaxel by the treating doctor.
• Have measurable cancer according to specific medical criteria.
• Have received at least one previous line of systemic therapy, with specific time intervals between treatments.
  • For small cell lung cancer, must have had first-line therapy with platinum doublet and anti-PD(L)1 therapy, if eligible.
  • For non-small cell lung cancer without a driver mutation, must have had first-line therapy with platinum doublet and anti-PD(L)1 therapy, if eligible.
  • For non-small cell lung cancer with a driver mutation, must have had FDA-approved targeted therapy and subsequent platinum doublet therapy, if eligible.
• Be at least 18 years old.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have normal bone marrow and organ function as determined by specific blood tests.
• Women of childbearing potential must agree to use effective contraception during the study and for one month after.
• Men must also agree to use effective contraception during the study and for one month after.
• Be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

• Have a history of other cancers, except for:
  • Cancers treated at least 2 years ago with no evidence of disease.
  • Certain skin cancers treated with local surgery.
  • Cervical carcinoma in situ.
  • Other tumors discussed with the study doctor.
• Currently receiving any other investigational drugs.
• Have had prior treatment with ADI-PEG 20 or gemcitabine (prior docetaxel is allowed).
• Have untreated or unstable brain metastases. Patients with treated and stable brain metastases are eligible.
• Have a history of allergic reactions to similar drugs used in the study.
• Have uncontrolled illnesses, such as ongoing infections, heart failure, unstable chest pain, or irregular heartbeats.
• Have a history of seizures not related to cancer.
• Have moderate or severe nerve damage.
• Be pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test before starting the study.
• Have active Hepatitis B, Hepatitis C, or HIV.