Small Cell Lung Cancer Clinical Trial
— ADRIATICOfficial title:
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)
| Verified date | May 2024 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy
| Status | Active, not recruiting |
| Enrollment | 730 |
| Est. completion date | September 5, 2024 |
| Est. primary completion date | September 5, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility | Inclusion criteria: 1. Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III). 2. Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules. 3. PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP. 4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy = 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment. Exclusion criteria: 1. Extensive-stage SCLC 2. Active or prior documented autoimmune or inflammatory disorders 3. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease. 4. Active infection including tuberculosis, HIV, hepatitis B and C 5. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy) |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Rosario | |
| Belgium | Research Site | Aalst | |
| Belgium | Research Site | Anderlecht | |
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | Roeselare | |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | CA |
| Canada | Research Site | Winnipeg | Manitoba |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Bengbu | |
| China | Research Site | Changchun | |
| China | Research Site | Changsha | |
| China | Research Site | Chengdu | |
| China | Research Site | Chongqing | |
| China | Research Site | Chongqing | |
| China | Research Site | Fuzhou | |
| China | Research Site | Hangzhou | |
| China | Research Site | Hefei | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shenyang | |
| China | Research Site | Shenyang | |
| China | Research Site | Tianjin | |
| China | Research Site | Wuhan | |
| China | Research Site | Wuhan | |
| China | Research Site | Wuhan | |
| China | Research Site | Yangzhou | |
| China | Research Site | Zhengzhou | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Olomouc | |
| Czechia | Research Site | Ostrava | |
| Czechia | Research Site | Praha | |
| Czechia | Research Site | Praha 2 | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Freiburg | |
| Germany | Research Site | Gauting | |
| Germany | Research Site | Gerlingen | |
| Germany | Research Site | Heidelberg | |
| Germany | Research Site | Köln | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Münster | |
| Germany | Research Site | Oldenburg | |
| Germany | Research Site | Regensburg | |
| Germany | Research Site | Wuerzburg | |
| India | Research Site | Bengaluru | |
| India | Research Site | Gurgaon | |
| Italy | Research Site | Brescia | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Orbassano | |
| Italy | Research Site | Parma | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Rozzano | |
| Italy | Research Site | Terni | |
| Japan | Research Site | Bunkyo-ku | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Fukuoka-shi | |
| Japan | Research Site | Iwakuni-shi | |
| Japan | Research Site | Kashiwa | |
| Japan | Research Site | Koto-ku | |
| Japan | Research Site | Kurume-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Niigata-shi | |
| Japan | Research Site | Osakasayama | |
| Japan | Research Site | Sakai-shi | |
| Japan | Research Site | Sapporo-shi | |
| Japan | Research Site | Sendai-shi | |
| Japan | Research Site | Sunto-gun | |
| Japan | Research Site | Tokushima-shi | |
| Japan | Research Site | Ube-shi | |
| Korea, Republic of | Research Site | Changwon-si | |
| Korea, Republic of | Research Site | Cheongju-si | |
| Korea, Republic of | Research Site | Daegu | |
| Korea, Republic of | Research Site | Goyang-si | |
| Korea, Republic of | Research Site | Jinju-si | |
| Korea, Republic of | Research Site | Seongnam-si | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Suwon-si | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Den Bosch | |
| Netherlands | Research Site | Groningen | |
| Netherlands | Research Site | Harderwijk | |
| Netherlands | Research Site | Hengelo | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Olsztyn | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Tomaszów Mazowiecki | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wroclaw | |
| Russian Federation | Research Site | Kazan | |
| Russian Federation | Research Site | Kirov | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Obninsk | |
| Russian Federation | Research Site | Omsk | |
| Russian Federation | Research Site | Ufa | |
| Russian Federation | Research Site | Volgograd | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Oviedo | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Valencia | |
| Spain | Research Site | Zaragoza | |
| Taiwan | Research Site | Hsinchu | |
| Taiwan | Research Site | Kaohsiung City | |
| Taiwan | Research Site | Keelung City | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Tainan City | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taoyuan City | |
| Taiwan | Research Site | Yunlin | |
| Turkey | Research Site | Adana | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Antalya | |
| Turkey | Research Site | Edirne | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Konya | |
| Turkey | Research Site | Samsun | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Truro | |
| United States | Research Site | Annapolis | Maryland |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Charleston | West Virginia |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Fort Myers | Florida |
| United States | Research Site | Fort Wayne | Indiana |
| United States | Research Site | Grand Rapids | Michigan |
| United States | Research Site | Hines | Illinois |
| United States | Research Site | Huntington | West Virginia |
| United States | Research Site | Kennewick | Washington |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Marietta | Georgia |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Muncie | Indiana |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Haven | Connecticut |
| United States | Research Site | New Hyde Park | New York |
| United States | Research Site | Orange City | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | Santa Rosa | California |
| United States | Research Site | Sioux Falls | South Dakota |
| United States | Research Site | Summit | New Jersey |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Towson | Maryland |
| United States | Research Site | Tucson | Arizona |
| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Ho Chi Minh |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Vietnam, Argentina, Belgium, Canada, China, Czechia, Germany, India, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Adverse Events | Approximately 6 years | ||
| Primary | Progression-free survival (PFS) | To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of PFS | Approximately 6 years | |
| Primary | Overall Survival (OS) | To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of OS | Approximately 6 years | |
| Secondary | Overall Survival (OS) | To assess the efficacy of Durvalumab & Tremelimumab combination therapy vs Placebo in terms of OS | Approximately 6 years | |
| Secondary | Objective Response Rate (ORR) | Approximately 6 years | ||
| Secondary | Progression-free survival PFS | To assess the efficacy of durvalumab and tremelimumab combination therapy compared to placebo in terms of PFS | Approximately 6 years | |
| Secondary | Progression-free survival at 18 months (PFS18) | Approximately 6 years | ||
| Secondary | Progression-free survival at 24 months (PFS24) | Approximately 6 years | ||
| Secondary | Time to death or distant metastasis (TTDM) | Approximately 6 years | ||
| Secondary | Proportion of patients alive at 24 months (OS24) | Approximately 6 years | ||
| Secondary | Proportion of patients alive at and 36 months (OS36) | Approximately 6 years | ||
| Secondary | Time from randomization to second progression (PFS2) | Approximately 6 years | ||
| Secondary | To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-C30 v3 | Approximately 6 years | ||
| Secondary | To assess the PK of durvalumab and tremelimumab in blood (peak trough concentration) | Approximately 6 years | ||
| Secondary | Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative) | Approximately 6 years | ||
| Secondary | PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS & ORR). | To investigate the relationship between PDL1 expression & spatial distribution with Durva (mono) therapy & Durva+Treme (combination) therapy | Approximately 6 years | |
| Secondary | To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-LC13 | Approximately 6 years |
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