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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-SB-S089 | Other Identifier | Eli Lilly and Company |
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This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).
A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Pemetrexed + Cisplatin | Experimental |
| |
| B: Pemetrexed + Carboplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Feasibility of Post-Surgery Chemotherapy | Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion. | every 21-day cycle for 4 cycles up to 30 days after last infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Grade III/IV Adverse Events | Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study. | every 21-day cycle for 4 cycles |
| Overall Survival at 3 Years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bordeaux | 33076 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed + Cisplatin | Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles |
| FG001 | Pemetrexed + Carboplatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| cisplatin | Drug | 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles |
|
| carboplatin | Drug | area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles |
|
For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date. |
| baseline to date of death from any cause, assessed at 3 years |
| 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years | For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years. | length of time disease free, assessed at 3 years |
| Overall Survival at 6 Years | For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date. | Baseline to date of death from any cause assessed at 6 years |
| France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Paris | 75571 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rennes | 35033 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saint-Priest-en-Jarez | 42270 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Toulouse | 31059 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bad Berka | 99437 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bielefeld | D-33604 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cologne | D-51109 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Großhansdorf | D-22927 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Halle | D-06120 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hanover | D-30625 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kassel | 34125 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Löwenstein | 74245 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mainz | D-55131 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mannheim | 68167 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | 08036 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madrid | 28046 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santiago de Compostela | 15706 | Spain |
Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed + Cisplatin | Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles |
| BG001 | Pemetrexed + Carboplatin | Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Curative Surgery Used | Number | participants |
| ||||||||||||||||
| Smoking History | Number | participants |
| ||||||||||||||||
| Stage of Disease Prior to Tumor Resection | Classification based on the American Joint Committee on Cancer Staging Criteria for Lung Cancer. | Number | participants |
| |||||||||||||||
| Tumor Type at Initial Pathological Diagnosis | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Feasibility of Post-Surgery Chemotherapy | Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion. | Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm). | Posted | Number | participants | every 21-day cycle for 4 cycles up to 30 days after last infusion |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Grade III/IV Adverse Events | Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study. | Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm). | Posted | Number | participants | every 21-day cycle for 4 cycles |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 3 Years | For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date. | All randomized participants. Intent to treat population. | Posted | Dec 2011 | Number | 95% Confidence Interval | percent probability of survival (%) | baseline to date of death from any cause, assessed at 3 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years | For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years. | All randomized participants. Intent to Treat population. | Posted | Dec 2011 | Number | 95% Confidence Interval | probability of disease-free survival (%) | length of time disease free, assessed at 3 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 6 Years | For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date. | All randomized participants. Intent to treat population. | Posted | Number | 95% Confidence Interval | percent probability of survival (%) | Baseline to date of death from any cause assessed at 6 years |
|
|
baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pemetrexed + Cisplatin | Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles | 18 | 64 | 61 | 64 | ||
| EG001 | Pemetrexed + Carboplatin | Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles | 5 | 54 | 52 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Visual disturbance | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Splenic artery aneurysm | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Keratoconjunctivitis sicca | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
A protocol amendment was approved after the trial original completed to allow for collection of additional overall survival data due to number of participants surviving at 3 years.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| African |
|
| Spain |
|
| Germany |
|
| Lobectomy |
|
| Bi-lobectomy |
|
| No |
|
| Stage Ib |
|
| Stage IIa |
|
| Stage IIb |
|
| Stage IIIa |
|
| Unknown: could have been either Stage IIIb or IV |
|
| Squamous Carcinoma of the Lung |
|
| Non-Small Cell Lung Cancer |
|
| Mixed Cell (Squamous/Adeno) Carcinoma of Lung |
|
| Large Cell Carcinoma of Lung |
|
| Bronchoalveolar Carcinoma |
|
| Non-feasible = Lost to Follow-up |
|
| Non-feasible = Remaining Grade 3/4 Toxicity |
|
| Non-feasible = Underdosage (<95% intended dose) |
|
| 50.0 |
| 95 |
| 36.1 |
| 63.9 |
| No |
| Superiority or Other |
|
|
| Participants |
|
|
|