Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Dexamethasone

Pemetrexed

Cisplatin

Dexamethasone acetate

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Trace Elements

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Folic Acid Antagonists

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles

75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size \[\<10 millimeter (mm) short axis\]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.

pCR after the participant has undergone surgery was calculated as: (total number of participants with pCR) divided by (the total number of participants in pathological response population) multiplied by 100.

Tumor downstaging compared to baseline (Stage IIIAN2) were those participants who exhibited a downward shift in tumor extent from Stage IIIAN2 to Stages IIIA, II, I, or 0 were reported. Downstaging was based on radiological examination. Stage IIIAN2 was locally advanced and/or involved lymph nodes, metastasis in ipsilateral mediastinal and or subcarinal lymph nodes, tumors were ≤2 centimeters (cm) up to 5 cm in greatest dimension; Stage IIIA was locally advanced and/or involved lymph nodes, tumor extension was restricted to the affected lung; Stage II was locally advanced and/or involved lymph nodes; Stage I was small localized cancers, usually curable; Stage 0 the cancer did not spread beyond the inner lining of the lung. Missing responses were also reported. Percentage of participants calculated as: (number of participants with a downward shift in extent of their tumor) divided by (total number of evaluable participants) multiplied by 100.

OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.

PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died or did not have objective progressive disease (PD) as of the data inclusion cut-off date, PFS was censored at the date of the last objective progression-free disease assessment. PD was defined using RECIST v1.1 criteria as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Eli Lilly and Company

Pemetrexed: 500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles

Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles

Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles

Age, Continuous

Sex: Female, Male

White

Race/Ethnicity, Customized

Italy

Region of Enrollment

ECOG classifies participants according to their functional impairment. Scores range from 0 (fully active) to 5 (death). 0 (fully active, able to carry on all pre-disease performance without restriction) and 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).

Eastern Cooperative Oncology Group (ECOG) Performance Status

Adenocarcinoma, Lung

Carcinoma, Large Cell, Lung

Carcinoma, Non-Small Cell, Lung

Initial cancer diagnosis confirmed by tissue biopsy.

Initial Pathological Diagnosis

T1aN2M0

T1bN2M0

T2aN2M0

T2bN2M0

T3N2M0

Tumor size: T1=surrounded by lung or visceral pleura with no evidence of invasion more proximal than lobar bronchus; T1a ≤2 centimeters (cm) at greatest dimension (GD); T1b \>2 cm, ≤3 cm at GD; T2=involves main bronchus, ≥2 cm distal to carina; invades visceral pleura, associated with atelectasis or obstructive pneumonitis extends to hilar but not entire lung; T2a \>3 cm, ≤5 cm at GD; T2b \>5 cm, ≤7 cm at GD; T3= \>7 cm or 1 that invades the thoracic cavity. Nodal status (N): N2 =Metastasis in ipsilateral mediastinal and/or subcarinal lymph nodes. Distant metastasis (M): M0 =No distant metastasis.

Tumor-Node-Metastasis (TNM) Stage of Disease

Current Tobacco User

Former Tobacco User

Never Used Tobacco

Tobacco Consumption Status

All participants who received at least 1 dose of chemotherapy.

Due to difficulties identifying suitable participants and enrollment delays, entries were closed after 26 of planned 33 participants signed consent. Results based on 19 participants who received ≥1 dose of chemotherapy. View results with caution.

Chief Medical Officer

Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

Participants who received at least 1 dose of preoperative chemotherapy and had surgical tumor tissue samples available.

Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]

No Change or Worsening of Tumor Stage

Change to Stage IIIA

Change to Stage II

Change to Stage I

Missing

Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0

All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=8

Overall Survival (OS)

All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=3.

Progression-Free Survival (PFS)

Overall Study

Spots Global Cancer Trial Database for A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial