Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Open-label, Multicenter, Randomized Phase II Trial of Treatment With Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients Affected by Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer With High Thymidylate Synthase Expression
This is an open-label, multicentre, randomized phase II trial.
Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase (TS)
expression , will be randomly assigned with 1:1 ratio to the following treatment Arms:
A. 4 cycles of Cisplatin + Oral Vinorelbine followed by maintenance with Metronomic Oral
Vinorelbine until disease progression
B. 4 cycles of Cisplatin + Pemetrexed followed by maintenance with Pemetrexed until disease
progression
Treatment will be repeated every 21 days .
An Open-label, Multicenter, Randomized Phase II Trial of Treatment with Cisplatin and
Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients affected by stage
IIIB-IV Non-Squamous Non-Small Cell Lung Cancer with high Thymidylate Synthase (TS)expression
After signing the informed consent for TS expression evaluation (see Appendix A), patients
will be tested for TS expression status of their tumor tissue.
If TS expression is more than 70 in the nucleus or ≥210 in nucleus and in the cytoplasm of
tumor cell, they will be categorized as high TS expression patients, and if it is less, they
will be considered as TS-negative.
Study Treatment:
Eligible patients will be randomly assigned to the following treatment Arms:
A. Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) + Cisplatin 80 mg/m2
on day 1 every 3 weeks, for 4 cycles.
Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday
and Friday continuously until disease progression, patient refusal or excessive toxicity (1
cycle: 3 weeks).
B. Pemetrexed, 500 mg/m2, day 1 + Cisplatin, 75 mg/m2, day 1 every 3 weeks, for 4 cycles.
Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks).
7-10 days before treatment administration, premedication with vitamin B12 1000µg
intramuscular injection (every 9 weeks) and folate 1mg every day should be commenced.
The total duration of the study will be 3 years. The enrollment period wil be 2 years and 1
year of follow up. Treatment period: until disease progression, intolerable toxicity or
patient refusal.
Number of Subjects :130 patients (65 patients per arm)
Statistical Methodology The primary variable of this study is Disease Control Rate (DCR).
According to primary variable, assuming a DCR≥70% for patients with high TS expression
treated with cisplatin and vinorelbine and a DCR=44% for patients with high TS expression
treated with cisplatin and pemetrexed, considering a 2-tailed alpha=0.05 and beta=0.10, it is
necessary to enroll 65 patients per arm (130 patients in total) in a 24-month period and the
subsequent 12-month follow-up.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
Completed |
NCT04426825 -
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT02810457 -
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02864394 -
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
|
Phase 3 | |
Recruiting |
NCT04592523 -
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
|
||
Recruiting |
NCT04838548 -
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT04077463 -
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT04603807 -
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
|
Phase 3 | |
Recruiting |
NCT05167604 -
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
|
||
Completed |
NCT04948411 -
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
|
||
Active, not recruiting |
NCT04487080 -
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Not yet recruiting |
NCT04255836 -
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
|
Phase 2 | |
Completed |
NCT01953913 -
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
|
Phase 3 | |
Recruiting |
NCT05715229 -
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
|
Phase 2 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Suspended |
NCT05421936 -
Osimertinib for NSCLC With Uncommon EGFR Mutations
|
||
Completed |
NCT02847377 -
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
|
N/A | |
Completed |
NCT04427072 -
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
|
Phase 3 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A |