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Phase 2 DoceRamPem for Patients With Metastatic or Recurrent NSCLC Who Progressed on Platinum-Doublet and PD-1/PD-L1 Blockade

Study acronym: DoceRamPem
StatusActive, Not Recruiting
PhasePhase 2
Started2020-06-05
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Primary completion confirmed: April 2026 (last estimated September 2026)
2026-07-29
2 amendments v12-v13
2 re-verifications since 2026-01-28, no change to tracked fields
2025-11-03
Study Status v11
Primary completion date2025-09-30→2026-09-02
2025-05-07
Recruiting→Active, Not Recruiting Study Identification, Study Status, Conditions, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-06-30→2025-09-30
Completion date2030-12-31→2030-09-30
Study sitesdetails revised at 2 of 2 sites
Study titlerevised
Phase 2 DoceRamPem for Patients withWith Metastatic or Recurrent NSCLC Who Progressed on Platinum-Doublet and PD-1/PD-L1 Blockade
2025-02-24
Study Identification, Study Status, Conditions, Study Design, Contacts/Locations v9
Enrollment target41→30
Study sitescontacts updated at 2 of 2 sites
Study titlerevised
Phase 2 DoceRamPem for Patients Withwith Metastatic or Recurrent NSCLC Who Progressed on Platinum-Doublet and PD-1/PD-L1 Blockade
Show 8 earlier versions
2024-02-10
Study Status, Contacts/Locations v8
Study sitesdetails revised at 2 of 2 sites
2023-03-05
Study Status, Sponsor/Collaborators, Study Description, Contacts/Locations, References v7
Primary completion date2023-06-30→2025-06-30
Completion date2024-12-31→2030-12-31
Study sites1→2
Study description-15 characters
[...] EOT). IV. To analyze the tumor infiltrating immune cells by singlemass cell ribonucleic acid (RNA) sequencingcytometry coupled to blood mass cytometry, in paired biopsies before and at end of after treatment. OUTLINE: After premedication, patients will [...]
2022-10-19
Study Identification, Study Status, Contacts/Locations v6
Primary completion date2023-04-25→2023-06-30
Completion date2023-05-31→2024-12-31
Study sitescontacts updated at 1 of 1 site
Study title+1 characters
Phase 2 TaxRamPemDoceRamPem for Patients With Metastatic or Recurrent NSCLC Who Progressed on Platinum-Doublet and PD-1/PD-L1 Blockade
2022-04-12
Study Status, Sponsor/Collaborators, Study Description, Contacts/Locations v5
Primary completion date2022-04-25→2023-04-25
Completion date2022-05-31→2023-05-31
2021-06-23
Study Status, Eligibility, Contacts/Locations v4
Eligibility criteria-265 characters
[...] rom the toxicity and/or complications from the intervention Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, [...] Patients with a prior or concurrent malignancy whose natural [...] infection requiring systemic therapy Has a known history of humanHuman immunodeficiencyImmunodeficiency virusVirus (HIV). Note: no HIV testing is required unless mandated by local [...] [...]
2020-06-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-06-01→confirmed 2020-06-05
Study sitesdetails revised at 1 of 1 site
2020-05-27
Study Status, Eligibility v2
Eligibility criteria-132 characters
[...] ooperative Oncology Group (ECOG) performance status of 0 to 21 Life expectancy > 12 weeks as determined by the investigato [...] of the investigational regimen are eligible for this trial Completion of all previous therapy (including surgery, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer > 3 weeks before the start of study therapy Patients with known history or current symptoms of cardiac d [...] anti-cancer therapy including investigational agents within 34 weeks or 5 times the half-life time, whichever is shorter [could consider shorter interval for kinase inhibitor [...]
2020-05-06
Study Status v1
Completion date2022-04-25→2022-05-31
Start date2020-04-23→2020-06-01
2020-04-08
Original filing
This phase 2 trial will evaluate the safety and efficacy of combining immunotherapy with a PD-1 checkpoint inhibitor (Pembrolizumab), an anti-VEGF receptor (Ramucirumab), and a taxane chemotherapy (Docetaxel) in treating patients with non-small cell lung cancer (NSCLC) who did not respond to FDA-approved treatments with platinum-based chemotherapy given concurrently or sequentially with anti-PD1/PD-L1 immunotherapy. Pembrolizumab helps the body's immune system to attack cancer cells and hinder their ability to grow and spread. Ramucirumab blocks new blood vessel growth to reduce tumor growth. Docetaxel works mainly by stopping cancer cells from dividing. Ramucirumab combined with docetaxel is an FDA-approved therapy for NSCLC patients after progression on platinum-based chemotherapy. It has shown to improve efficacy compared to docetaxel alone in this setting. Pembrolizumab is an FDA-approved treatment for NSCLC and can be given alone or in combination with platinum-based chemotherapy. Investigators hypothesize that the combination of docetaxel, ramucirumab, and pembrolizumab will be safe and more effective than the current standard of care treatments (docetaxel alone or in combination with ramucirumab) in patients with metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and immunotherapy, given concurrently or sequentially.
Trial Details
NCT Number NCT04340882
Lead Sponsor Emory University
Collaborators: National Cancer Institute (NCI), Merck Sharp & Dohme LLC
Conditions Metastatic Non-Small Lung Cell Cancer, Recurrent Non-Small Lung Cell Cancer, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Enrollment 30 participants
Start Date 2020-06-05
Primary Completion 2026-04-30 (estimated)
Study Completion 2030-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-24