Carcinoma, Non-Small-Cell LungPhase 2NCT06709859
Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC
A Phase 2 study testing Afatinib plus chemotherapy as conversion treatment in people with Carcinoma, Non-Small-Cell Lung, run by Shandong Public Health Clinical Center at 1 site in China.
Trial summary
This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Afatinib plus chemotherapy as conversion treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator.
- Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation
- ECOG Performance Status of 0-1
- At least one measurable lesion according to RECIST 1.1
- Adequate organ and marrow function
Who cannot join
- Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma
- The presence of malignant pleural effusion
- Prior systemic anti-cancer therapy for non-small cell lung cancer
- Prior local radiotherapy for NSCLC
- Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Public Health Clinical Center
Jinan, Shangdong, 250000
hua zhang, 0531-83347512, 95192789@qq.com
About this study
Official title: A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer
This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
Read the detailed description
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Afatinib plus chemotherapy as conversion treatment
- Keywords
- Conversion Therapy, Afatinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afatinib plus chemotherapy as conversion treatmentDrug
Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection.
| Study group | Role | What they receive |
|---|---|---|
| Afatinib plus chemotherapy | Experimental | Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment (afatinib 40mg qd; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for non-squamous carcinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then surgery will be provided for patients who are suitable for primary tumor resection. Maintenance treatment with afatinib 40mg qd will continue up to 2 years or disease progression after surgery. Receives: Drug: Afatinib plus chemotherapy as conversion treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of NSCLC converting to resectable tumors
The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy.
Measured: Up to 12 weeks
Secondary outcomes (9)
R0 resection rate
The proportion of R0 resection in patients who receive surgery
Measured: immediately after the surgery
Major pathologic response (MPR) Rate
The proportion of patients who achieve MRP among those receiving surgery
Measured: Up to 12 weeks
Pathologic complete response (pCR) Rate
The proportion of patients who achieve pCR among those receiving surgery
Measured: Up to 12 weeks
Tumor downstaging rate
The proportion of patients who reach the successful downstaging criteria for NSCLC
Measured: Up to 12 weeks
Objective response rate (ORR)
The proportion of patients who have a complete response (CR) or partial response (PR).
Measured: Up to five years
Disease control rate (DCR)
The proportion of patients who have a best overall response of CR, PR, or stable disease (SD).
Measured: Up to five years
Event-free survival (EFS)
The length of time after initial administration the patient remains free of recurrence/progression or death, whatever the cause.
Measured: Up to five years
The 2-year progression-free survival (PFS) rate
The proportion of patients who are event-free.
Measured: Up to two years
Overall Survival (OS)
The length of time after initial administration the patient remains alive
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 May 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hua Zhang, PhD, Principal investigator, Shandong Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709859
- Sponsor's protocol ID
- GWLCZXEC2024-56-2
- Status last verified
- Jul 2025
- First submitted
- 26 Nov 2024
- Last updated
- 17 Jul 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06709859
- Acronym / sponsor ID
- GWLCZXEC2024-56-2
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Conversion Therapy, Afatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong Public Health Clinical CenterOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Nov 2024 (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.
This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
Detailed description
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib plus chemotherapy | Experimental | Drug: Afatinib plus chemotherapy as conversion treatmentPatients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment (afatinib 40mg qd; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for non-squamous carcinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then surgery will be provided for patients who are suitable for primary tumor resection. Maintenance treatment with afatinib 40mg qd will continue up to 2 years or disease progression after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator.
- Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation
- ECOG Performance Status of 0-1
- At least one measurable lesion according to RECIST 1.1
- Adequate organ and marrow function
Key exclusion criteria (5 listed)
- Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma
- The presence of malignant pleural effusion
- Prior systemic anti-cancer therapy for non-small cell lung cancer
- Prior local radiotherapy for NSCLC
- Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment
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 |
|---|---|---|
| Afatinib plus chemotherapy as conversion treatmentPatients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection. | Drug | Afatinib plus chemotherapy |
Primary outcome
The rate of NSCLC converting to resectable tumors
Time frame: Up to 12 weeks
The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy.
9 secondary outcomes
R0 resection rate
Time frame: immediately after the surgery
Major pathologic response (MPR) Rate
Time frame: Up to 12 weeks
Pathologic complete response (pCR) Rate
Time frame: Up to 12 weeks
Tumor downstaging rate
Time frame: Up to 12 weeks
Objective response rate (ORR)
Time frame: Up to five years
Disease control rate (DCR)
Time frame: Up to five years
Event-free survival (EFS)
Time frame: Up to five years
The 2-year progression-free survival (PFS) rate
Time frame: Up to two years
Overall Survival (OS)
Time frame: Up to five years
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 17 Jul 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.
Hua Zhang, PhD principal investigator
Shandong Public Health Clinical Center
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 Afatinib plus chemotherapy as conversion treatment in people with Carcinoma, Non-Small-Cell Lung, run by Shandong Public Health Clinical Center 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 5 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: looking for participants now, as of the sponsor's last update on 17 Jul 2025. 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?
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 Hua Zhang, PhD (0531-83347512, 95192789@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of NSCLC converting to resectable tumors (time frame: Up to 12 weeks). 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 17 Jul 2025.