Non-Squamous Non-Small Cell Lung Cancer Clinical Trial
Official title:
Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.
| Verified date | September 2017 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.
| Status | Completed |
| Enrollment | 144 |
| Est. completion date | June 20, 2017 |
| Est. primary completion date | June 20, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult patients, >/= 18 years of age - Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria - EGFR mutation-positive disease according to local laboratory testing - Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice Exclusion Criteria: - Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized >6 months prior to receiving Tarceva - Participation in another clinical study - Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario Principe de Asturias; Servicio de Oncologia | Alcala de Henares | Madrid |
| Spain | Fundacion Hospital de Alcorcon; Servicio de Oncologia | Alcorcon | Madrid |
| Spain | Hospital Virgen de los Lirios; Servicio de Oncologia | Alcoy | Alicante |
| Spain | Hospital de Cruces; Servicio de Oncologia | Barakaldo | Vizcaya |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | |
| Spain | Hospital Universitario Puerta del Mar; Servicio de Oncologia | Cádiz | Cadiz |
| Spain | Hospital Universitario Reina Sofia; Servicio de Oncologia | Cordoba | |
| Spain | Hospital del Henares; Servicio de Oncologia | Coslada | Madrid |
| Spain | Hospital Universitario San Cecilio; Servicio de Oncologia | Granada | |
| Spain | Hospital General de Granollers; Servicio de Oncologia | Granollers | Barcelona |
| Spain | Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaen | |
| Spain | Hospital Universitario de Canarias (HUC) | La Laguna (Tenerife) | Tenerife |
| Spain | Hospital General de Lanzarote | Lanzarote | Las Palmas |
| Spain | Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia | Las Palmas de Gran Canaria | Las Palmas |
| Spain | Complejo Asistencial Universitario de Leon; Servicio de Oncologia | Leon | |
| Spain | Complejo Hospitalario Xeral-Cies | Lugo | |
| Spain | Hospital Universitario de Mostoles;Servicio de Oncologia | Madrid | |
| Spain | Hospital Universitario La Paz; Servicio de Oncologia | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Madrid | |
| Spain | Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia | Malaga | |
| Spain | Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Murcia | |
| Spain | Complejo Hospitalario de Orense; Servicio de Oncologia | Orense | |
| Spain | Hospital Univ. Central de Asturias | Oviedo | Asturias |
| Spain | Hospital Son Llatzer; Servicio de Oncologia | Palma de Mallorca | Islas Baleares |
| Spain | Hospital Universitario Son Espases; Servicio de Oncologia | Palma De Mallorca | Islas Baleares |
| Spain | Hospital de Sagunto; Servicio de Oncologia | Sagunto | Valencia |
| Spain | Hospital Clinico Universitario de Salamanca; Servicio de Oncologia | Salamanca | |
| Spain | Hospital de Donostia; Servicio de Oncologia Medica | San Sebastian | Guipuzcoa |
| Spain | Hospital Infanta Sofia; Servico de Oncologia | San Sebastian de Los Reyes | Guipuzcoa |
| Spain | Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia | Santa Cruz de Tenerife | Tenerife |
| Spain | Hospital Universitario Marques de Valdecilla; Servicio de Oncologia | Santander | Cantabria |
| Spain | Hospital General de Segovia; Servicio de Oncologia | Segovia | |
| Spain | Hospital Universitario Virgen Macarena; Servicio de Oncologia | Sevilla | |
| Spain | Hospital Mutua de Terrassa; Servicio de Oncologia | Terrassa | Barcelona |
| Spain | Hospital General de Teruel Obispo Polanco; Servicio Oncologia | Teruel | |
| Spain | Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia | Valencia | |
| Spain | Hospital Universitario Dr. Peset; Servicio de Oncologia | Valencia | |
| Spain | Hospital Clinico Universitario de Valladolid; Servicio de Oncologia | Valladolid | |
| Spain | Hospital Meixoeiro | Vigo | Pontevedra |
| Spain | Hospital Lluis Alcanys; Servicio de Oncologia | Xativa | Valencia |
| Spain | Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia | Zamora | |
| Spain | Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics | 3 years | ||
| Secondary | Objective response rate, tumor assessments according to RECIST v1.1 criteria | 3 years | ||
| Secondary | One-year overall survival (from initiation of treatment to 12 months after disease progression) | 3 years | ||
| Secondary | Time to progression | 3 years | ||
| Secondary | Exposure (dosage/duration) with first-line Tarceva in clinical practice | 3 years | ||
| Secondary | Safety: Incidence of adverse events | 3 years | ||
| Secondary | Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression | 3 years | ||
| Secondary | Treatments used after disease progression in clinical practice | 3 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02264990 -
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
|
Phase 3 | |
| Completed |
NCT01328951 -
A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
|
Phase 3 | |
| Completed |
NCT01664533 -
An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy
|
N/A | |
| Completed |
NCT00976456 -
Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer
|
Phase 3 | |
| Completed |
NCT00988936 -
Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
|
Phase 2 | |
| Completed |
NCT02596958 -
Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants
|
N/A | |
| Completed |
NCT00974584 -
A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT00451906 -
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
|
Phase 4 | |
| Completed |
NCT03329911 -
A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer
|
Phase 3 | |
| Not yet recruiting |
NCT03671538 -
Non Squamous NSCLC Patients With Anlotinib Combined With Pemetrexed and Cisplatin
|
N/A | |
| Completed |
NCT01512420 -
An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)
|
N/A | |
| Completed |
NCT01204697 -
A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
|
Phase 2 | |
| Completed |
NCT01185847 -
A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT00760929 -
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
|
Phase 2 | |
| Withdrawn |
NCT03319316 -
Combination of Durvalumab and Tremelimumab as Maintenance Treatment in Patients With Non Squamous and Squamous (NSCLC)
|
Phase 2 | |
| Recruiting |
NCT06334757 -
Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure
|
Phase 2 | |
| Recruiting |
NCT06396065 -
Phase III Study of AK112 for NSCLC Patients
|
Phase 3 | |
| Completed |
NCT01174563 -
A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy
|
Phase 2 | |
| Completed |
NCT01836133 -
An Observational Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
|
N/A | |
| Completed |
NCT01763671 -
Paclitaxel-bevacizumab in Advanced Lung Cancer
|
Phase 3 |