New strategy aims to tame treatment side effects in lung cancer patients
NCT ID NCT07469488
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special care plan to help Chinese patients with advanced EGFR-mutated lung cancer who are taking the drug amivantamab. The plan focuses on preventing common side effects like blood clots, skin rashes, and infusion reactions. About 122 adults will join to see if this approach improves their quality of life and reduces treatment-related problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 122 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent. * Participants have a confirmed diagnosis of locally advanced or metastatic EGFR-mutated NSCLC (Stage IIIB/C or IV). * Participant \[and/or their legally authorized representative where applicable\] must sign an ICF allowing source data verification in accordance with local requirements and indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study. * Participants have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1. * Participants with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed. * Be eligible for, and agree to comply with, the use of enhanced dermatologic management and enhanced IRR prophylaxis management during the duration of anticancer treatments with amivantamab and lazertinib, or amivantamab with chemotherapy. Cohort 1 (cEGFR 1L): * EGFR mutation must be an Ex19del or Ex21 L858R substitution. * Participants who plan to receive Amivantamab (IV form) and Lazertinib regimen treatment based on physician's medical judgement. * Participant is treatment-naive and not amenable to curative therapy including surgical resection or (chemo)radiation. Adjuvant or neoadjuvant therapy is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease. * Be eligible for, and agree to comply with, the use of prophylactic-dose anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of anticancer treatment (from Day 1-120) according to Chinese Society of Clinical Oncology (CSCO) guidelines. Cohort 2 (cEGFR 2L): * EGFR mutation must be an Ex19del or Ex21 L858R substitution. * Participants who plan to receive Amivantamab (IV form) and Chemotherapy regimen treatment based on physician's medical judgement. * Participants must have progressed on or after prior therapy including an EGFR TKI for advanced or metastatic NSCLC. Amivantamab and chemotherapy will be received as a second-line treatment. Cohort 3 (EGFR Ex20ins 1L): * EGFR mutation must be an EGFR Ex20ins. * Participants who plan to receive Amivantamab (IV form) and Chemotherapy regimen treatment based on physician's medical judgement. * Participant is treatment-naive and not amenable to curative therapy including surgical resection or (chemo)radiation. Adjuvant or neoadjuvant therapy for is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease. Exclusion Criteria: * Pregnancy or breastfeeding. * Is currently enrolled in an interventional clinical study. * Any condition for which, at the investigator's discretion, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Pulmonary Hospital
Shanghai, China
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