Lung Cancer, Non-small CellPhase 2APPEALNCT04592666
Almonertinib/Pemetrexed/Carboplatin in EGFR T790M+ Advanced Lung Cancer
A Phase 2 study testing Almonertinib, Pemetrexed and Carboplatin in people with Lung Cancer, Non-small Cell and EGFR T790M, run by Fudan University at 1 site in China.
Trial summary
Almonertinib Plus Pemetrexed and Carboplatin Versus Almonertinib Alone in Advanced NSCLC With EGFR T790M After First- or Second-generation TKIs Therapy: a Randomized, Controlled, Open-label, Phase 2 Study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Non-small Cell, EGFR T790M, EGFR Gene Mutation
- What is being tested?
- Almonertinib, Pemetrexed and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 75 years old (including 18 and 75 years old);
- Histologically or cytologically confirmed locally advanced or metastatic (STAGE IIIB-IV) NSCLC does not accept simple sputum smear-based diagnosis;
- Previous genetic tests confirmed egFR-sensitive mutations, and received one or two generations of EGFR TKI treatment. After drug resistance, it was confirmed to be positive for EGFR T790M mutation by biopsy or free DNA test.
- The patient has at least one tumor lesion that has not received local treatment such as radiation or biopsy in the screening stage, and can be accurately measured at baseline, with the longest diameter ≥ 10mm at baseline (short diameter ≥ 15mm if lymph nodes are involved).The measurement method chosen is suitable for accurate repeated measurements and can be computed tomography (CT) or magnetic resonance imaging (MRI).If there is only one measurable lesion and no previous local treatment such as irradiation, it can be accepted as the target lesion for baseline evaluation of tumor lesions after at least 14 days of diagnostic biopsy.
- Life expectancy is at least 3 months;
- ECOG score: 0-1, with no significant clinical deterioration in the past 2 weeks;
- The main organs function normally, that is, they meet the following standards:
- blood routine examination standards must be in accordance with no blood transfusion and adjuvant therapies (14 days) : A. Hemoglobin (HB) ≥90 g/L; B. Absolute value of neutrophils (ANC) ≥1.5×109/L; C. Platelet (PLT) ≥100×109/L; D. Total bilirubin (TBIL) <1.5 times the upper limit of normal value (ULN); E. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5×ULN, if accompanied by liver metastasis, ALT and AST< 5×ULN; F. Serum Cr<1.25×ULN or endogenous creatinine clearance rate (CCr) > 45 ml/min (Cockcroft-Gault formula);
Who cannot join
- Patients who have received three generations of EGFR-TKI treatment;
- Patients with mixed small cell lung cancer components;
- Patients with advanced or metastatic disease who have received palliative chemotherapy, or patients with tumor recurrence and metastasis within 6 months after radical surgery with adjuvant chemotherapy;
- Patients with symptomatic brain metastasis, meningeal metastasis or spinal cord compression;
- Patients with previous diagnosis of interstitial pneumonia;
- Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite the best medication);
Show all 18Show fewer
- with severe cardiovascular disease: Ⅱ magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher);According to NYHA standard, Ⅲ ~ Ⅳ cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) < 50%;
- abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5uln), bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: Under the condition that the international standard ratio of prothrombin time (INR) ≤1.5, low-dose heparin (daily dosage for adults ranges from 66,000 to 12,000 U) or low-dose aspirin (daily dosage ≤100 mg) is allowed for preventive purposes.
- Peripheral neuropathy ≥CTCAE 2 is present, except for trauma;
- Respiratory syndrome (≥CTCAE level 2 dyspnea), uncontrolled serous cavity effusion (including pleural effusion, ascites and pericardial effusion);
- A wound or fracture that has not been healed for a long time;
- Severe infections requiring systemic antibiotics;
- Decompensated diabetes mellitus or other contraindications of high-dose glucocorticoid therapy;
- Active hepatitis C and/or hepatitis B infection (hepatitis B: HBsAg positive with HBV DNA≥500IU/mL;Hepatitis C: HCV RNA positive);
- Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Had major surgery or severe traumatic injury, fracture or ulcer within the first 4 weeks;
- Any contraindications for platinum (carboplatin) and cytotoxic drug (Pemetrexed) treatment;
- Other conditions deemed inappropriate by the researcher for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Almonertinib Plus Pemetrexed and Carboplatin Versus Almonertinib Alone in Advanced NSCLC With EGFR T790M After First- or Second-generation TKIs Therapy: a Randomized, Controlled, Open-label, Phase 2 Study
Almonertinib Plus Pemetrexed and Carboplatin Versus Almonertinib Alone in Advanced NSCLC With EGFR T790M After First- or Second-generation TKIs Therapy: a Randomized, Controlled, Open-label, Phase 2 Study
- Conditions
- Lung Cancer, Non-small Cell, EGFR T790M, EGFR Gene Mutation
- Being tested
- Almonertinib, Pemetrexed, Carboplatin
- Keywords
- lung cancer, EGFR, Combination therapy, Almonertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmonertinibDrug
the standard therapy of single agent almonertinib
PemetrexedDrug
standard dose
CarboplatinDrug
AUC=5
| Study group | Role | What they receive |
|---|---|---|
| Combinational therapy | Experimental | Not described Receives: Drug: Almonertinib; Drug: Pemetrexed; Drug: Carboplatin |
| Single TKI | Active comparator | Not described Receives: Drug: Almonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start9 Oct 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-small CellStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592666
- Sponsor's protocol ID
- ALMO-PEME-CAR-01
- Acronym
- APPEAL
- Status last verified
- Oct 2020
- First submitted
- 22 Sep 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: based on preliminary results
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almonertinib Plus Pemetrexed and Carboplatin Versus Almonertinib Alone in Advanced NSCLC With EGFR T790M After First- or Second-generation TKIs Therapy: a Randomized, Controlled, Open-label, Phase 2 Study
- ClinicalTrials.gov ID
- NCT04592666
- Acronym / sponsor ID
- APPEAL / ALMO-PEME-CAR-01
- Conditions
- Lung Cancer, Non-small Cell, EGFR T790M, EGFR Gene Mutation
- Keywords
- lung cancer, EGFR, Combination therapy, Almonertinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Almonertinib Plus Pemetrexed and Carboplatin Versus Almonertinib Alone in Advanced NSCLC With EGFR T790M After First- or Second-generation TKIs Therapy: a Randomized, Controlled, Open-label, Phase 2 Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combinational therapy | Experimental | Drug: Almonertinib, Drug: Pemetrexed, Drug: Carboplatin |
| Single TKI | Active comparator | Drug: Almonertinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between 18 and 75 years old (including 18 and 75 years old);
- Histologically or cytologically confirmed locally advanced or metastatic (STAGE IIIB-IV) NSCLC does not accept simple sputum smear-based diagnosis;
- Previous genetic tests confirmed egFR-sensitive mutations, and received one or two generations of EGFR TKI treatment. After drug resistance, it was confirmed to be positive for EGFR T790M mutation by biopsy or free DNA test.
- The patient has at least one tumor lesion that has not received local treatment such as radiation or biopsy in the screening stage, and can be accurately measured at baseline, with the longest diameter ≥ 10mm at baseline (short diameter ≥ 15mm if lymph nodes are involved).The measurement method chosen is suitable for accurate repeated measurements and can be computed tomography (CT) or magnetic resonance imaging (MRI).If there is only one measurable lesion and no previous local treatment such as irradiation, it can be accepted as the target lesion for baseline evaluation of tumor lesions after at least 14 days of diagnostic biopsy.
- Life expectancy is at least 3 months;
Key exclusion criteria (18 listed)
- Patients who have received three generations of EGFR-TKI treatment;
- Patients with mixed small cell lung cancer components;
- Patients with advanced or metastatic disease who have received palliative chemotherapy, or patients with tumor recurrence and metastasis within 6 months after radical surgery with adjuvant chemotherapy;
- Patients with symptomatic brain metastasis, meningeal metastasis or spinal cord compression;
- Patients with previous diagnosis of interstitial pneumonia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almonertinibthe standard therapy of single agent almonertinib | Drug | Combinational therapy, Single TKI |
| Pemetrexedstandard dose | Drug | Combinational therapy |
| CarboplatinAUC=5 | Drug | Combinational therapy |
Primary outcome
PFS
Time frame: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)
progression free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Undecided. based on preliminary results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Almonertinib, Pemetrexed and Carboplatin in people with Lung Cancer, Non-small Cell and EGFR T790M, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.