Clinical trial · Interventional
LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer
LCI-LUN-ABR-001: A Pilot Study of Carboplatin With Nab-Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer of Squamous Histology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ABRAXANE, based on results from prior studies, is a promising drug in squamous cell carcinoma of the lung. This study will help to explore the combination of ABRAXANE and carboplatin more thoroughly in the subgroup of patients who had the best response in prior studies as well as determine whether there are any biomarkers which can predict for response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carboplatin + Abraxane
- description
- Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
- interventionNames
- Drug: Carboplatin
- Drug: Abraxane
Primary outcomes (1)
- measure
- Number of Participants With a Response
- timeFrame
- Up to a planned 18 weeks
- description
- The primary endpoint is a binary variable determined for each patient indicating whether or not they achieved a complete response (CR) or a partial response (PR) as per RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions and a PR is indicated by \>= 30% decrease in sum of longest diameter of target lesions with baseline as reference). Because overall response is the primary endpoint for this study, best responses of CR or PR must be confirmed by a subsequent radiologic assessment.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage IV non-small cell lung cancer with predominantly squamous histology * No prior systemic treatment for metastatic disease. Patients who have received prior adjuvant chemotherapy for early-stage lung cancer are eligible if at least 12 months have elapsed between the date of final chemotherapy administration and the date of consent * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>20 mm with conventional techniques or as \>10 mm with CT scan, MRI, or calipers by clinical exam * Biopsy accessible disease * Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Definitive radiation therapy must have been completed \>4 weeks prior to the date the informed consent is signed * Age \>18 years * ECOG performance status less than or equal to 1 * If patient has brain metastasis, the disease must be stable (treated and/or asymptomatic) for at least 4 weeks prior to first dose of study treatment * Bilirubin \< 1.5 mg/dL * Adequate liver function: AST and ALT \<= 2.5x upper limit of normal, alkaline phosphatase \<= 2.5x upper limit of normal, unless bone metastasis is present (\< 5x upper limit of normal) in the absence of liver metastasis * Adequate bone marrow function: Platelets \>100,000 cells/mm3, Hemoglobin \> 9.0g/dL and ANC \> 1,500 cells/mm3 * Adequate renal function with creatinine \<1.5 mg/dL is recommended * Females of childbearing potential and sexually active males must use an effective contraception method during treatment and for six months after completing treatment * Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential * Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE version 4.0) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria * Received prior systemic therapy for metastatic disease * Received limited field radiation for palliation \<= 2 weeks prior to starting study treatment and/or from whom \>= 30% bone marrow was irradiated * Receiving any other investigational agents * Known hypersensitivity to either carboplatin or ABRAXANE * Uncontrolled and current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or breast feeding * Other active malignancies * Neuropathy greater than or equal to grade 2
References
Publications (0)
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