Phase 2 Study of DoceRamPem for Patients with Advanced or Returning Non-Small Cell Lung Cancer After Standard Treatments

Sponsor: Emory University

Sponsor score: 40

ClinicalTrials ID:NCT04340882

Provider View

This clinical trial is testing a new combination of treatments for patients with non-small cell lung cancer (NSCLC) that has spread or returned after standard treatments. The study combines three drugs: Pembrolizumab, Ramucirumab, and Docetaxel, to see if they work better together than current treatments.

Patient Parameters

Program Overview

This study aims to find out if a new combination of three drugs—Pembrolizumab, Ramucirumab, and Docetaxel—can safely and effectively treat patients with non-small cell lung cancer (NSCLC) that has spread or come back after standard treatments. Pembrolizumab helps the immune system attack cancer cells, Ramucirumab blocks blood vessel growth to slow tumor growth, and Docetaxel stops cancer cells from dividing. Researchers believe this combination might be more effective than current treatments for patients whose cancer has progressed after receiving platinum-based chemotherapy and immunotherapy.

Description

The main goal of this study is to see if the combination of Pembrolizumab, Ramucirumab, and Docetaxel can keep the cancer from getting worse for at least six months. Researchers will also look at how safe the treatment is and how well patients tolerate it. They will monitor any side effects related to the immune system and measure how many patients respond to the treatment and how long they live after starting it.

The study will also explore how certain genetic markers and immune cell changes might affect treatment response. Patients will receive the three drugs through an IV on the first day of each 21-day cycle. Treatment will continue until the cancer progresses, severe side effects occur, or the patient or doctor decides to stop.

The first six patients will be closely monitored for safety. If the treatment is safe, more patients will be enrolled to assess its effectiveness. Patients whose cancer progresses or who start a new treatment will be followed up regularly to check their survival status for up to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer (NSCLC).
  • Cancer has progressed after platinum-based chemotherapy and PD-1 or PD-L1 immunotherapy.
  • Men must use contraception during treatment and for 120 days after the last dose.
  • Women must not be pregnant or breastfeeding and must use contraception if of childbearing potential.
  • Must provide written consent to participate.
  • Have measurable cancer based on specific criteria.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Life expectancy of more than 12 weeks.
  • Meet specific blood count and organ function requirements.
  • Completed any necessary palliative radiotherapy more than a week before starting the study.
  • Any side effects from previous treatments must be mild or resolved.
  • Patients with other cancers that do not interfere with this study are eligible.
  • Patients with heart disease must have a risk assessment and be class 2B or better.

Exclusion Criteria

  • Women with a positive pregnancy test before treatment.
  • Previous treatment with Docetaxel or Ramucirumab.
  • Significant protein in urine or kidney issues.
  • Recent treatment with other cancer therapies or investigational drugs.
  • Recent radiotherapy or live vaccines.
  • Participation in another clinical trial within four weeks.
  • Immune system deficiencies or chronic steroid use.
  • Active brain metastases or severe allergies to study drugs.
  • Uncontrolled illnesses or heart conditions.
  • Recent major bleeding or clotting events.
  • Active autoimmune diseases requiring treatment.
  • History of lung inflammation or immune-related side effects.
  • Active infections or known HIV, Hepatitis B, or C infections.
  • Psychiatric or substance abuse issues affecting study participation.
  • Pregnant or breastfeeding, or planning to conceive during the study.

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