deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT02590003

Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer

A Randomized Phase II Trial of Combination Versus Single Agent Chemotherapy in High-risk Elderly Patients With Advanced Non-small Cell Lung Cancer

Sponsor: Yale University

Conditions Carcinoma, Non-small Cell Lung
Interventions Carboplatin Nab-paclitaxel
Updated 8 times since 2017 Last updated: Jan 30, 2018 Started: Nov 30, 2015 Primary completion: Sep 30, 2016 Completion: Sep 30, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Trial was stopped after non-response to treatment.

A PHASE2 clinical study on Carcinoma, Non-small Cell Lung, this trial is terminated or withdrawn. The trial is conducted by Yale University and has accumulated 8 data snapshots since 2015. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

The primary objective of this trial is to compare the treatment failure-free survival rate in high-risk elderly patients, identified by geriatric assessment, treated with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel in advanced non-small cell lung cancer. Treatment failure-free survival is the most appropriate primary outcome as it captures excessive toxicity due to chemotherapy in addition to death and disease progression. The secondary objectives are to evaluate grade 3-5 toxicities, overall response rate, progression free survival, symptom assessment, and overall survival between the two randomization arms.

The primary objective of this trial is to compare the treatment failure-free survival rate in high-risk elderly patients, identified by geriatric assessment, treated with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel in advanced non-small cell lung cancer. Treatment failure-free survival is the most appropriate primary outcome as it captures excessive toxicity due to chemotherapy in addition to death and disease progression.

The secondary objectives are to evaluate grade 3-5 toxicities, overall response rate, progression free survival, symptom assessment, and overall survival between the two randomization arms.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotRecruiting~Feb 2017 – ~Nov 2017 · 9 months · monthly snapshotRecruiting~Nov 2017 – ~Mar 2018 · 4 months · monthly snapshotCompleted~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

8 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

  5. Mar 2018 — Jun 2018 [monthly]

    Terminated PHASE2

    Status: Completed → Terminated

▶ Show 3 earlier versions

  1. Nov 2017 — Mar 2018 [monthly]

    Completed PHASE2

    Status: Recruiting → Completed

  2. Feb 2017 — Nov 2017 [monthly]

    Recruiting PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Nov 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Yale University
Data source: Yale University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations