Lung AdenocarcinomaPhase 2OOTERNCT06818955
Orlistat Overcoming Third-generation EGFR-TKI Resistance
A Phase 2 study testing Orlistat 120 mg in people with Lung Adenocarcinoma and Osimertinib, run by Ping Peng.
Trial summary
EGFR mutation positivity accounts for 50% of lung adenocarcinoma cases. Multiple clinical trials, represented by FLAURA, AENEAS, and FURLONG studies, have confirmed that third-generation EGFR-TKI can provide significant benefits to patients with EGFR sensitive mutations and has become the first-line preferred… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Adenocarcinoma, Osimertinib
- What is being tested?
- Orlistat 120 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2025to 15 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously received three generations of systemic TKI treatment and developed resistance (including Axitinib, Amitinib, Fumatinib, Bevatinib, Lazetinib, etc.);
- General condition score ECOG 0-2 points;
- Expected survival period of more than 3 months;
- Laboratory examination:
- ① WBC≥3.5×109／L，ANC≥1.5×109／L，PLT≥80×109／L， Hb≥90g/L；
- ② Blood BUN and creatinine are within 1.5 times the upper limit of normal values;
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- ③ TBIL ≤ 1.5 times the upper limit of normal value;
- ④ ALT and AST ≤ 2.5 times the upper limit of normal values; Patients with liver metastasis should not exceed 5 times the upper limit of normal values;
- ⑤ Normal coagulation function (PT, APTT within 1.5 times the upper limit of normal range).
- The patient requests to continue taking targeted drugs orally
- Voluntarily sign the informed consent form, with expected compliance.
Who cannot join
- Suffering from serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, serious infection, and active gastrointestinal ulcer;
- A large amount of pleural and pericardial effusion requires immediate treatment;
- Brain metastases with clinical symptoms;
- Pregnant or lactating women;
- The patient is able to tolerate chemotherapy and is willing to accept it
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on the Safety and Efficacy of Orlistat in Third-generation EGFR-TKI Resistance
EGFR mutation positivity accounts for 50% of lung adenocarcinoma cases. Multiple clinical trials, represented by FLAURA, AENEAS, and FURLONG studies, have confirmed that third-generation EGFR-TKI can provide significant benefits to patients with EGFR sensitive mutations and has become the first-line preferred treatment for EGFR mutation positive NSCLC, with a median PFS of around 19 and OS of around 38 months. These large-scale Phase III studies have confirmed the excellent efficacy of third-generation EGFR-TKI in EGFR mutation positive patients. However, regardless of the targeted drug, resistance will occur within less than 2 years. Blood test data for first-line treatment with osimertinib showed that the most common forms of resistance were secondary MET amplification (20%), EGFR C797S mutation (8%), PIK3CA, Her-2 amplification, and so on. The mechanism of resistance is complex and has many factors. Currently, for the treatment of third-generation EGFR-TKI resistance, the IMPOWER150 and ORIENTAL31 treatment modes are commonly used. Although the combination of these four drugs has good efficacy, the side effects are significant. Some patients are unwilling to undergo chemotherapy due to physical problems and hope to continue taking targeted drugs orally. Orlistat is a long-acting and potent specific gastrointestinal lipase inhibitor that can directly block the absorption of body fat. It is commonly used for weight loss in clinical practice and is relatively inexpensive. Our project team found in vitro and in vivo data that orlistat can effectively promote sensitivity to osimertinib. The combination of orlistat and osimertinib can overcome osimertinib resistance without significant toxic side effects. For patients who are unwilling to undergo chemotherapy and require continued oral targeted therapy, the investigators attempted to add orlistat to see if it can improve resistance.
- Conditions
- Lung Adenocarcinoma, Osimertinib
- Being tested
- Orlistat 120 mg
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orlistat 120 mgDrug
Orlistat 120 mg po tid
| Study group | Role | What they receive |
|---|---|---|
| orlistat group | Experimental | For patients who are resistant to osimertinib and require continued oral administration of targeted drugs, we will add orlistat Receives: Drug: Orlistat 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall response rate (ORR) was defined as the combination of CR and PR.
Measured: At the end of cycle 3 (each cycle is 21 days)
Secondary outcomes (1)
Safety (Rate of grade 3 and higher grade treatment-related adverse events)
Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0)
Measured: From date of treatment allocation until treatment completion 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start16 Feb 2025 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ping Peng
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Cancer Hospital
- Responsible party
- Sponsor-investigator, Ping Peng, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818955
- Sponsor's protocol ID
- EGFR-TKI resistance study
- Acronym
- OOTER
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Orlistat in Third-generation EGFR-TKI Resistance
- ClinicalTrials.gov ID
- NCT06818955
- Acronym / sponsor ID
- OOTER / EGFR-TKI resistance study
- Conditions
- Lung Adenocarcinoma, Osimertinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ping PengUniversity, hospital or other
- Collaborators
- Hubei Cancer Hospital
- Study start
- 16 Feb 2025 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 11 Feb 2025 (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.
EGFR mutation positivity accounts for 50% of lung adenocarcinoma cases. Multiple clinical trials, represented by FLAURA, AENEAS, and FURLONG studies, have confirmed that third-generation EGFR-TKI can provide significant benefits to patients with EGFR sensitive mutations and has become the first-line preferred treatment for EGFR mutation positive NSCLC, with a median PFS of around 19 and OS of around 38 months. These large-scale Phase III studies have confirmed the excellent efficacy of third-generation EGFR-TKI in EGFR mutation positive patients. However, regardless of the targeted drug, resistance will occur within less than 2 years. Blood test data for first-line treatment with osimertinib showed that the most common forms of resistance were secondary MET amplification (20%), EGFR C797S mutation (8%), PIK3CA, Her-2 amplification, and so on. The mechanism of resistance is complex and has many factors. Currently, for the treatment of third-generation EGFR-TKI resistance, the IMPOWER150 and ORIENTAL31 treatment modes are commonly used. Although the combination of these four drugs has good efficacy, the side effects are significant. Some patients are unwilling to undergo chemotherapy due to physical problems and hope to continue taking targeted drugs orally. Orlistat is a long-acting and potent specific gastrointestinal lipase inhibitor that can directly block the absorption of body fat. It is commonly used for weight loss in clinical practice and is relatively inexpensive. Our project team found in vitro and in vivo data that orlistat can effectively promote sensitivity to osimertinib. The combination of orlistat and osimertinib can overcome osimertinib resistance without significant toxic side effects. For patients who are unwilling to undergo chemotherapy and require continued oral targeted therapy, the investigators attempted to add orlistat to see if it can improve resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| orlistat group | Experimental | Drug: Orlistat 120 mgFor patients who are resistant to osimertinib and require continued oral administration of targeted drugs, we will add orlistat |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Previously received three generations of systemic TKI treatment and developed resistance (including Axitinib, Amitinib, Fumatinib, Bevatinib, Lazetinib, etc.);
- General condition score ECOG 0-2 points;
- Expected survival period of more than 3 months;
- Laboratory examination:
- ① WBC≥3.5×109／L，ANC≥1.5×109／L，PLT≥80×109／L， Hb≥90g/L；
Key exclusion criteria (5 listed)
- Suffering from serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, serious infection, and active gastrointestinal ulcer;
- A large amount of pleural and pericardial effusion requires immediate treatment;
- Brain metastases with clinical symptoms;
- Pregnant or lactating women;
- The patient is able to tolerate chemotherapy and is willing to accept it
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 |
|---|---|---|
| Orlistat 120 mgOrlistat 120 mg po tid | Drug | orlistat group |
Primary outcome
ORR
Time frame: At the end of cycle 3 (each cycle is 21 days)
Overall response rate (ORR) was defined as the combination of CR and PR.
1 secondary outcome
Safety (Rate of grade 3 and higher grade treatment-related adverse events)
Time frame: From date of treatment allocation until treatment completion 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orlistat 120 mg in people with Lung Adenocarcinoma and Osimertinib, run by Ping Peng.
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 11 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ping Peng, PhD (008613429818576, pengpingtj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: At the end of cycle 3 (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 12 Feb 2025.