Lung Adenocarcinoma Clinical Trial
Official title:
A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers
This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.
PRIMARY OBJECTIVES:
I. To determine the distribution of progression-free survival (PFS) in patients with
previously untreated advanced adenocarcinoma of the lung who are never or light former
smokers treated with either OSI-774 (erlotinib) (erlotinib hydrochloride) alone (arm A) or in
combination with carboplatin/paclitaxel (arm B).
SECONDARY OBJECTIVES:
I. To determine the radiographic response rate in patients with previously untreated advanced
adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774
(erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
II. To determine the frequency of epidermal growth factor receptor (EGFR) and V-Ki-ras2
Kirsten rat sarcoma viral oncogene homolog (K-ras) mutations and anaplastic lymphoma kinase
(ALK) translocations in patients with previously untreated advanced adenocarcinoma of the
lung who are never or light former smokers.
III. To determine the response rate and time to progression in patients with and without EGFR
mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with
carboplatin/paclitaxel (arm B).
IV. To determine the response rate and time to progression in patients with and without K-ras
mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with
carboplatin/paclitaxel (arm B).
V. To determine the median and overall survival of patients with previously untreated
advanced adenocarcinoma of the lung who are never or light former smokers treated with either
OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
VI. To estimate the response rate, progression-free, and overall survival of patients with
echinoderm microtubule associated protein like (EML)4-ALK translocation who received OSI-774
erlotinib alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21.
Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive erlotinib hydrochloride as in Arm I. Patients also receive
paclitaxel intravenously (IV) over 1-3 hours and carboplatin IV over 15-30 minutes on day 1.
Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or
unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to
receive erlotinib hydrochloride alone as above.
After completion of study treatment, patients are followed at least every 3 months for 1 year
and then every 6 months for up to 2 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02898857 -
Chemoresistance and Involvement of the NOTCH Pathway in Patients With Lung Adenocarcinoma
|
N/A | |
| Completed |
NCT02127359 -
Whole-Exome Sequencing (WES) of Cancer Patients
|
||
| Recruiting |
NCT01249066 -
Expression of AMP-activated Protein Kinase (AMPK) Protein in Lung Adenocarcinoma
|
N/A | |
| Not yet recruiting |
NCT04482829 -
TCM in the Treatment of Lung Adenocarcinoma
|
N/A | |
| Recruiting |
NCT04929041 -
Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative
|
Phase 2/Phase 3 | |
| Terminated |
NCT04691375 -
A Study of PY314 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT02621333 -
Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT02282267 -
Blood Detection of EGFR Mutation For Iressa Treatment
|
N/A | |
| Not yet recruiting |
NCT01942629 -
Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas
|
N/A | |
| Recruiting |
NCT01482585 -
Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy
|
N/A | |
| Recruiting |
NCT03376737 -
Study of Apatinib as the Maintenance Therapy in Advanced Lung Adenocarcinoma
|
Phase 2 | |
| Recruiting |
NCT05537922 -
I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
|
||
| Recruiting |
NCT04937283 -
Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
|
N/A | |
| Recruiting |
NCT06255197 -
Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
|
||
| Completed |
NCT02093000 -
A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma
|
N/A | |
| Recruiting |
NCT04119024 -
Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
|
Phase 1 | |
| Terminated |
NCT04682431 -
A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05736991 -
Deep Learning Signature for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma
|
||
| Enrolling by invitation |
NCT05136014 -
Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model
|
||
| Terminated |
NCT05012397 -
Milademetan in Advanced/Metastatic Solid Tumors
|
Phase 2 |