NCT03944772 - Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) | Biotech Hunter

Enrollment

247

Participants

Timeline

Start Date

June 25, 2019

Primary Completion Date

May 6, 2025

Study Completion Date

May 6, 2025

Conditions

Non-Small Cell Lung Cancer

Interventions

DRUG

Osimertinib

Osimertinib given orally at 80 mg once daily

DRUG

Savolitinib

Savolitinib will be given orally at 300 mg or 600mg once daily

DRUG

Gefitinib

Gefitinib given orally at 250 mg once daily

DRUG

Necitumumab

Necitumumab given IV at 800 mg on Day 1 and Day 8 of every 3-week cycle

DRUG

Durvalumab

Durvalumab given IV at 1500 mg on Day 1 of every cycle

DRUG

Carboplatin

Carboplatin given IV on Day 1 of every 21-day cycle for up to 6 cycles

DRUG

Pemetrexed

Pemetrexed given IV at 500 mg/m2 body BSA on Day 1 of every cycle

DRUG

Alectinib

Alectinib given orally at 600mg twice daily and for Japanese patients at 300mg twice daily.

DRUG

Selpercatinib

Selpercatinib given orally at 160mg twice daily

DRUG

Selumetinib

Selumetinib given orally at 75 mg twice daily for 4 days, followed by 3 days off treatment

DRUG

Etoposide

Etoposide 80-100 mg/m2 given IV on day 1, 2 and 3 of every 21-day cycle for up to 4 cycles.

DRUG

Cisplatin

Cisplatin 75-80 mg/m2 given IV on days 1 of each cycle

DRUG

Datopotamab deruxtecan

Datopotamab deruxtecan given IV at 4 or 6 mg/kg on Day 1 of every 3-week cycle.

Trial Locations (47)

3004

Research Site, Drammen

5000

Research Site, Odense C

7030

Research Site, Trondheim

10017

Research Site, New York

10032

Research Site, New York

10043

Research Site, Orbassano

13620

Research Site, Seongnam-si

15006

Research Site, A Coruña

15232

Research Site, Pittsburgh

17176

Research Site, Stockholm

21100

Research Site, Varese

21224

Research Site, Baltimore

28041

Research Site, Madrid

28046

Research Site, Madrid

35128

Research Site, Padua

41009

Research Site, Seville

49503

Research Site, Grand Rapids

60612

Research Site, Chicago

77030

Research Site, Houston

80131

Research Site, Napoli

90048

Research Site, Los Angeles

90404

Research Site, Santa Monica

91010

Research Site, Duarte

95123

Research Site, Catania

95817

Research Site, Sacramento

97239

Research Site, Portland

98109

Research Site, Seattle

06510

Research Site, New Haven

02114

Research Site, Boston

02215

Research Site, Boston

104-0045

Research Site, Chūōku

812-8582

Research Site, Fukuoka

135-8550

Research Site, Kōtoku

464-8681

Research Site, Nagoya

541-8567

Research Site, Osaka

641-8510

Research Site, Wakayama

1066 CX

Research Site, Amsterdam

1081 HV

Research Site, Amsterdam

6229 HX

Research Site, Maastricht

6525 GA

Research Site, Nijmegen

3015GD

Research Site, Rotterdam

N-0310

Research Site, Oslo

03722

Research Site, Seoul

05505

Research Site, Seoul

06351

Research Site, Seoul

08025

Research Site, Barcelona

08036

Research Site, Barcelona