Phase 2 Parkinson's Disease Trial, Recruiting NCT04165070 Sponsor: Merck Sharp & Dohme LLC Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Recruiting

NCT04165070
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:

  • People who have been confirmed through a tissue or cell sample test to have Stage IV non-small cell lung cancer (NSCLC), either the squamous or non-squamous type
  • People with non-squamous NSCLC for whom a doctor-approved targeted therapy is not considered suitable
  • People who are able to provide a tumor tissue sample — either one stored from within the last 5 years (or since completing their last treatment), or a newly collected biopsy taken from an area not previously treated with radiation, within 90 days before starting the trial treatment
  • People who have not yet received any systemic (whole-body) treatment for their advanced/metastatic NSCLC
  • People who are able to complete all required pre-trial check-ups within 35 days (Part A) or 28 days (Part B) of beginning the screening process

Who may not be able to join:

  • People who have been diagnosed with small cell lung cancer
  • People who have an immune system deficiency, or who have been taking steroid medications above a certain daily dose, or any other immune-suppressing medication in the 7 days before the first trial treatment
  • People who have another cancer (in addition to NSCLC) that is currently growing or has required active treatment within the past 2 years
  • People who have active cancer spread to the brain or spinal fluid lining (confirm with trial site)
  • People who have an autoimmune disease that has needed systemic (whole-body) treatment within the past 2 years
  • People who have a history of lung inflammation (not caused by infection) that required steroid treatment, or who currently have lung inflammation
  • People who have an active infection that requires systemic (whole-body) treatment
  • People with serious heart conditions, including unstable chest pain, a heart attack within the past 6 months, or severe heart failure
  • People with a known history of HIV infection — though people with well-controlled HIV managed with anti-retroviral therapy are not automatically excluded
  • People with known Hepatitis B surface antigen in their blood, unless they have been on Hepatitis B antiviral treatment for at least 4 weeks and their viral load is undetectable before the trial begins; people with active Hepatitis C infection are not eligible
  • People who have had major surgery within 3 weeks before the first trial treatment
  • People who are expected to need another form of cancer treatment during the trial
  • People who have a bowel condition (such as Crohn's disease or ulcerative colitis), significantly impaired liver function, or another condition that a doctor believes could interfere with how oral medications are absorbed or processed
  • People receiving chemotherapy who have active diverticulitis, an abscess in the abdomen, a bowel blockage, or cancer spread throughout the abdominal cavity
  • People who already have moderate or worse nerve damage (neuropathy)
  • People who have previously received systemic chemotherapy, targeted therapy, or biological cancer treatment for their metastatic disease
  • People who are unwilling or unable to take folic acid or vitamin B12 supplements, if they are assigned to receive a chemotherapy drug called pemetrexed
  • People with a known allergy or sensitivity to carboplatin, paclitaxel, pemetrexed, or any of their ingredients
  • People who have received radiation to the lung above a certain dose level within 6 months before the first trial treatment
  • People who have received a live vaccine within 30 days before the first trial treatment — approved COVID-19 mRNA, adenoviral, or inactivated vaccines are permitted, but investigational (unapproved) vaccines are not
  • People who have previously received immunotherapy and had to stop it due to a severe or worse immune-related side effect
  • People who have had chemotherapy or biological cancer therapy within 4 weeks before the first trial treatment, or whose side effects from earlier cancer treatment have not sufficiently resolved
  • People who are currently taking part in, or have taken part in, another clinical trial involving an experimental treatment or device within the past 4 weeks
  • People who have previously had a severe allergic reaction to a monoclonal antibody treatment (including pembrolizumab) or any of their ingredients
  • People who have received a transplant of donor tissue or a solid organ

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 8 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.

Contact this trial

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

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 December 2019
Est. completion
13 February 2032

Where this trial is recruiting

🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇦 Ukraine 🇺🇸 United States

Primary endpoints

Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); Part B: Number of Participants Who Experience One or More Adverse Events (AEs); Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE); Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

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: 8 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