Clinical trial with or without chemotherapy after surgical resection of the primary lung cancer in patients with high risk of relapse based on the Pervenio? Lung RS Assay

A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I Non-Squamous Non-Small Cell Lung Cancer Identified as High Risk by the Pervenio? Lung RS Assay

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001494-24-ES

Enrollment

1050

Registered

2013-09-16

Start date

2013-10-24

Completion date

Unknown

Last updated

2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Completely resected stage I non-squamous non-small cell lung cancer (NSCLC) MedDRA version: 14.1 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000004864

Interventions

Trade Name: CISPLATIN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CISPLATIN CAS Number: 64.569 Current Sponsor code: SUB07483MIG Other descriptive name: Cisplatin F

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent (the informed consent document must have been approved by the appropriate Institutional Review Board/Independent Ethics Committee (IRB/IEC). Consent must be obtained and signed and witnessed PRIOR to any study specific activity. 2. Age ? 18 years 3. Able to comply with the protocol, including follow-up especially for anticipated length of study (i.e. 5 years from the initiation of enrollment). 4. Histologically documented completely resected (R0) Stage I non-squamous NSCLC. Eligible resections include lobectomy, bi-lobectomy, sleeve lobectomy and pneumonectomy. Resections via segmentectomy or wedge resection will not be eligible. Complete resection must also be accompanied, at a minimum, by intra-operative systematic mediastinal lymph node sampling. Systematic sampling is defined as removal of at least one representative lymph node each from levels 4 and 7 for a right-sided cancer and from levels 5 and/or 6 and 7 for left-sided cancers. Complete mediastinal lymph node dissection (MLND), however, is preferred, and is defined as resection of all lymph nodes at those same levels for right- and left-sided cancers. 5. Adequate tissue sample available for Pervenio testing (paraffin block with tumor occupying at least 25% of the tissue surface area) 6. Life expectancy excluding NSCLC diagnosis ? 5 years 7. ECOG performance status 0-1 8. Adequate haematological function*: a. Absolute neutrophil count (ANC) ? 1500 cells/mm3 AND b. Platelet count ? 100000 cells/mm3 AND c. Haemoglobin ? 9 g/dL (may be transfused to maintain or exceed this level) 9. Adequate liver function*: a. Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 350

Exclusion criteria

Exclusion criteria: 1. Final pathologic diagnosis on resected specimen is squamous cell histology 2. Evidence of greater than stage I pathologic staging, including loco-regional regional (hilar) or mediastinal lymph node involvement or nodal enlargement that has not been biopsied, or of distant metastatic disease (lesions that have been biopsy-proven or that are suspicious on brain MRI and/or PET scan) 3. Evidence of incomplete resection, including positive resection margins, additional suspect nodules 4. Pregnant or lactating women 5. Women with an intact uterus (unless amenorrhoeic for the previous 24 months) unwilling to use an effective means of contraception (including oral contraceptive, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of study chemotherapy. Men who do not agree to use effective contraception during the study and for a period of 90 days following the last administration of study chemotherapy. 6. Active infection, either systemic or at site of primary resection 7. Any pre-operative systemic chemotherapy or treatment with an anti-cancer agent 8. Any pre-or post operative radiotherapy to primary site or elsewhere 9. Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent 10. Treatment with any investigational drug or participation in another clinical trail within 28 days prior to enrollment. 11. Known hypersensitivity to any of the study treatment agents. 12. Evidence of any other disease including infection (see above) such as neurologic or metabolic dysfunction or physical examination finding giving reasonable suspicion of a disease or condition that contraindicates the use of systemic cytotoxic chemotherapy or puts the patient at high risk for treatment related complications.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to compare OS in patients with resected, stage I nonsquamous NSCLC who are found to be at high risk by the Pervenio? Lung RS Assay and who are subsequently randomized to either observation or adjuvant therapy with four cycles of cisplatin plus vinorelbine, so as to document the benefit of personalizing patient care based on molecular prognostic data.;Secondary Objective: 1. To compare DFS in patients randomized to each study arm. 2. To further document the previously documented of survival curves among high- and low-risk patients identified by the Pervenio? assay in this prospective cohort of stage I non- squamous NSCLC patients. 3. To collect fresh frozen and formalin-fixed paraffin-embedded (FFPE) tissue specimens from a subset of patients with consent for full clinical annotation for future analysis of molecular and genetic correlates of disease.;Primary end point(s): The primary endpoint of the study is the duration of overall survival (OS) in patients determined to be at High-Risk by the Pervenio? Lung RS assay.;Timepoint(s) of evaluation of this end point: OS is defined to be the time from randomization to death. Patients alive at the end of the analysis will be censored at their last known alive date.	—

Measure

Time frame

Main Objective: The primary objective of this study is to compare OS in patients with resected, stage I nonsquamous NSCLC who are found to be at high risk by the Pervenio? Lung RS Assay and who are subsequently randomized to either observation or adjuvant therapy with four cycles of cisplatin plus vinorelbine, so as to document the benefit of personalizing patient care based on molecular prognostic data.;Secondary Objective: 1. To compare DFS in patients randomized to each study arm. 2. To further document the previously documented of survival curves among high- and low-risk patients identified by the Pervenio? assay in this prospective cohort of stage I non- squamous NSCLC patients. 3. To collect fresh frozen and formalin-fixed paraffin-embedded (FFPE) tissue specimens from a subset of patients with consent for full clinical annotation for future analysis of molecular and genetic correlates of disease.;Primary end point(s): The primary endpoint of the study is the duration of overall survival (OS) in patients determined to be at High-Risk by the Pervenio? Lung RS assay.;Timepoint(s) of evaluation of this end point: OS is defined to be the time from randomization to death. Patients alive at the end of the analysis will be censored at their last known alive date.

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Key Secondary Endpoint: Disease-free survival (DFS) 2. An additional secondary endpoint of the trial is to compare overall survival (OS) in patients identified by the Pervenio RS assay as high-risk stage I non-squamous NSCLC randomized to observation (Arm A) with patients identified by the Pervenio RS assay as low-risk stage I non-squamous NSCLC.;Timepoint(s) of evaluation of this end point: 1. Time from randomization to disease recurrence, new primary lung cancer, or death from any cause. Patients without events at the end of the analysis will be censored at their last known event-free date. 2. OS is defined to be the time from randomization to death. Patients alive at the end of the analysis will be censored at their last known alive date.	—

Measure

Time frame

Secondary end point(s): 1. Key Secondary Endpoint: Disease-free survival (DFS) 2. An additional secondary endpoint of the trial is to compare overall survival (OS) in patients identified by the Pervenio RS assay as high-risk stage I non-squamous NSCLC randomized to observation (Arm A) with patients identified by the Pervenio RS assay as low-risk stage I non-squamous NSCLC.;Timepoint(s) of evaluation of this end point: 1. Time from randomization to disease recurrence, new primary lung cancer, or death from any cause. Patients without events at the end of the analysis will be censored at their last known event-free date. 2. OS is defined to be the time from randomization to death. Patients alive at the end of the analysis will be censored at their last known alive date.

—

Countries

China, France, Germany, Spain, United States

Contacts

Public ContactProf. Dr. Heiko E. von der Leyen

Hannover Clinical Trial Center GmbH

vdleyen@clinical-trial-center.de00495115333330

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026