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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Concomitant Medication; Adverse Experiences (Non-serious); Course Conclusion

- 27/04/21 - 1 modulo, 7 itemgroups, 31 elementi, 1 linguaggio
Itemgroups: Administrative, Concomitant Medication, Adverse Experiences (Non-serious), Adverse Experiences (Non-serious), Investigator's Signature (Adverse Experience), Course Conclusion, Investigator's Signature (Study Conclusion)
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

- 27/04/21 - 1 modulo, 4 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: Administrative, Serious Adverse Experiences, Vital Signs , 12-Lead Electrocardiogram
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 21/04/21 - 1 modulo, 4 itemgroups, 28 elementi, 1 linguaggio
Itemgroups: Administrative, Laboratory Tests - Haematology, Laboratory Tests - Blood Chemistry, Laboratory Tests - Urinalysis
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Eligibility Criteria

- 20/04/21 - 1 modulo, 5 itemgroups, 27 elementi, 1 linguaggio
Itemgroups: Administrative, Inclusion Criteria, Exclusion Criteria, Inclusion/ Exclusion, Investigator's Signature
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Prior an Concomitant Medication; Telephone Randomisation

- 18/04/21 - 1 modulo, 4 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Administrative, Prior and Concomitant Medication, Prior and Concomitant Medication , Telephone Randomisation
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

- 17/04/21 - 1 modulo, 9 itemgroups, 20 elementi, 1 linguaggio
Itemgroups: Administrative, Toxicities related to previous Radiotherapy for SCLC, Toxicities related to previous Radiotherapy for SCLC, 12-Lead Electrocardiogram, Diagnostic Studies for Tumor Assessment, Ongoing Medical Conditions Associated with SCLC, Ongoing Medical Conditions Associated with SCLC, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Screening - Subject Identification; Demography; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions

- 15/03/21 - 1 modulo, 12 itemgroups, 64 elementi, 1 linguaggio
Itemgroups: Inform Screening, Subject number, Date of Visit/ Assessment, Local Laboratories, Subject identification, Demography, Disease Characteristics, Metastatic Disease, Status at Screening, Anti-Cancer Therapy, Anti-Cancer Therapy , Medical Conditions
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

- 10/11/20 - 1 modulo, 2 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01563354 according to the information on clinicaltrials.gov "other protocol-defined inclusion/exclusion-criteria may apply"

Eligibility Lung Neoplasms NCT01717482

- 11/07/20 - 1 modulo, 2 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01717482

Eligibility Lung Neoplasms NCT01266512

- 11/07/20 - 1 modulo, 2 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01266512

Eligibility Lung Neoplasms NCT01109524

- 10/07/20 - 1 modulo, 2 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01109524

Eligibility Lung Carcinoma NCT02285660

- 10/07/20 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition; ODM derived from: https://clinicaltrials.gov/show/NCT02285660

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