PALOMA-2
Research type
Research Study
Full title
A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer.
IRAS ID
1006215
Contact name
Caitlin Young
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2022-000526-21
ISRCTN Number
ISRCTN11527992
Clinicaltrials.gov Identifier
Research summary
Metastatic NSCLC is an advanced form of cancer that has spread from the lungs to other areas of the body. Amivantamab targets the epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor receptor (MET). Amivantamab as an injection in a vein is being developed in variety of indications for lung cancer. A subcutaneous formulation (injection under the skin) of amivantamab (SC-CF) is being developed to improve patient experience.
This study aims to confirm that amivantamab SC-CF has similar anti-cancer activity similar to what is seen in amivantamab as an injection in a vein in combination regimens.
This study will include male and female participants 18 years old or above.
Participants will be randomly divided into 4 groups as shown below and will receive:
1. Group 1:
- Amivantamab SC-CF 1600 milligrams (mg)/ 2240 mg on Cycle 1 Days 1, 8, 15, and 22 and on Day 1 and 15 of each next 28-day cycle, starting with Cycle 2, and lazertinib 240 mg orally once daily.
2. Group 2:
- Amivantamab SC-CF 2560 mg/ 3360 mg on Cycle 1 Days 1, 8, and 15 and on Day 1 of each next 21-day cycle, starting with Cycle 2, carboplatin 750 mg every 3 weeks (Q3W) up to 4 cycles and pemetrexed 500 milligrams per meter square (mg/m*2) Q3W.
3. Group 3
- Amivantamab SC-CF 2560 mg/ 3360 mg on Cycle 1 Days 1, 8, and 15 and on Cycle 1 Days 1, 8, and 15 and on Day 1 of each next 21-day cycle, starting with Cycle 2, lazertinib 240 mg orally once daily, carboplatin 750 mg Q3W up to 4 cycles and pemetrexed 500 mg/m*2 Q3W.
4. Group 4:
- Amivantamab SC-CF 1600 mg/ 2240 mg in each cycle 28-day cycle, lazertinib 240 mg orally once daily (where applicable).Amivantamab doses will be based on body weight.
During the study, various tests will be performed that includes blood tests, physical examinations, ECG, ECOG, vital signs, eye tests, and questionnaires. All side effects will be recorded until study ends (up to 1 year and 5 months).
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0349
Date of REC Opinion
22 Nov 2022
REC opinion
Further Information Favourable Opinion