Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy
CompletedPhase 2Results postedLast updated 29 September 2021
What this trial tests
Phase 2 trial testing Abraxane in Patients With Stage IV or Recurrent Adenocarcinoma of the Lung in 37 participants. Completed in 30 April 2020.
18 and older, any sex, with Patients With Stage IV or Recurrent Adenocarcinoma of the Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response RatePrimary· Averaging about 16 weeks.
The percentage of patients with a Partial Response or Complete Response recorded from the start of the treatment until disease progression/recurrence by RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameter of target lesions; Overall Response (OR) = CR + PR.
Group
Value
95% CI
Gemcitabine + Paciltaxel
13.5
2.5 – 24.5
Progression-free SurvivalSecondary· Averaging about 16 weeks
Measures the length of time from the first day of therapy until Progressive Disease, death from any cause, or last patient contact. Disease Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Gemcitabine + Paciltaxel
2.6
1.4 – 3.8
Overall SurvivalSecondary· Averaging about 47 weeks
Length of time from the first day of therapy to death from any cause or last patient contact
Group
Value
95% CI
Gemcitabine + Paciltaxel
6.2
4.2 – 8.2
Disease Control RateSecondary· The duration of study treatment, averaging about 16 weeks.
The percentage of patients with a Partial Response, a Complete Response, or Stable Disease during the study. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameter of target lesions; Overall Response (OR) = CR + PR.
Group
Value
95% CI
Gemcitabine + Paciltaxel
59.5
43.5 – 75.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main purpose of this study is to see how well the combination of Abraxane and gemcitabine works in people with advanced adenocarcinoma NSCLC who have already had treatment for their disease. Gemcitabine and Abraxane are FDA approved chemotherapies; however, the FDA has not approved this combination in the treatment of this specific type of cancer. Patients may continue to receive the study drugs until their disease gets worse or they have unacceptable side effects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine
Last refreshed: 29 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02303977.