Small Cell Lung CarcinomaPhase 2NCT04363255
First-line Chemotherapy Followed by Toripalimab Combined With Anlotinib for Maintenance in ES-SCLC
A Phase 2 study testing Etoposide Injection, Carboplatin Injection and Cisplatin injection in people with Small Cell Lung Carcinoma, run by Taizhou Hospital at 2 sites in China.
Trial summary
Our aim in this study was to evaluate the efficacy and safety of etoposide combined with cisplatin or carboplatin (EC/EP) chemotherapy regimens followed by toripalimab combined with anlotinib for maintenance in extensive small cell lung cancer(ES-SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Etoposide Injection, Carboplatin Injection and Cisplatin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2020to 31 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients must sign a specific informed consent form prior to clinical trial; 2. Extensive stage small cell lung cancer confirmed by histology or cytology; 3. Patients did not receive any system treatment before or only received EP/EC chemotherapy (time from the last medication of chemotherapy to the beginning of maintenance treatment must be ≤21 days); 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 5. An estimated survival duration of >5 months from the beginning of chemotherapy; 6. Age no less than 18; 7. A measurable lesion on image; 8. Patients with asymptomatic brain metastases or symptomatic brain metastases which were stable after treatment; 9. Before the first dose of drugs for study, patients should have appropriate organ function and the laboratory results must meet conditions as following: Blood routine examination: neutrophil absolute value (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin content (HGB) ≥9g/dl; Adequate hepatic function: bilirubin ≤1.5×ULN mg/dl, creatinine clearance ≥ 50 ml/min; Adequate hepatic function: Aspartate aminotransferase (AST) /alanine aminotransferase (ALT)> 2.5 × upper limit of normal (ULN) or > 5 × ULN (patients with liver metastasis), alkaline phosphatase (ALP) ≤2.5×ULN or ≤5×ULN (patients with bone metastasis), Total bilirubin (TB) ≤1.5×ULN, albumin (ALB)>30g/dl; Coagulation function: international normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN; Urine routine: 24-hour urine protein<1g (if urine protein ≥2+, additional 24-hour urine protein is required); Others: serum lipase or amylase ≤1.5×ULN or >1.5×ULN (subjects clinically or radiologically diagnosed with pancreatitis).
Who cannot join
- 1. Patients received EP/EC regiment received the last medication ≥21 days before maintenance treatment, or received other systematic anti-tumor treatment for ES-SCLC; 2. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation; 3. Patients received any other experimental drugs or participated in another interventional clinical study within 4 weeks prior to signing the informed consent; 4. Patients received other systemic or local antitumor therapy (including but not limited to the use of other drugs for SCLC maintenance therapy or radiotherapy, but CR/PR subjects are allowed to use prophylactic cranial irradiation (PCI) after induction period treatment); 5. Patients with active and untreated brain metastases or carcinoma meningitis in CT or MRI examination during screening stage; 6. Patients with other malignant tumors within 5 years, except for curable malignant tumors (carcinoma in situ or stage I tumor), such as cervical carcinoma in situ, basal cell or squamous cell skin cancer and so on); 7. Patients received corticosteroids (>10mg/ day methyl prednisolone or equivalent dose) or other immunosuppressants (inhalation or local use of steroids and adrenal replacement treatment were permitted in the absence of an active autoimmune disease) less than 14 days prior to maintenance medications; 8. Patients with chronic or acute active hepatitis B (HBsAg positive and hepatitis B virus (HBV) DNA copy number >ULN), or HCV positive (HCV Ab positive and HCV RNA positive); Hepatitis B patients with previous HBV infection or who have been cured (HBsAg negative, HBcAb positive and HBV DNA copy number < ULN) were allowed to be enrolled; 9. Patients with interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or active pneumonia with clinical symptoms; or other lung diseases causing moderate or severe lung dysfunction; Active pulmonary tuberculosis or the need for anti-tuberculosis treatment; 10. Patients who were allergy to one of research drugs, or allergy to any one of the immunocheckpoint inhibitors or other platinum; 11. Female patients during pregnant and lactation period, or patients were plan to pregnant; 12. Patients with factors that may cause the study to be forced to terminate halfway according to investigators' judgement, such as poor compliance, other serious diseases requiring combined treatment and so on.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Enze Hospital, affiliated Taizhou Hospital of Wenzhou Medical University
Taizhou, Zhejiang
Dongqing Lv, MD, 13867622009, lvdq@enzemed.com
Dongqing Lv, MD
Haihua, Yang
Taizhou, Zhejiang
Haihua Yang, MD, 13819639006, yhh93181@hotmail.com
Haihua Yang, MD
About this study
Official title: Efficacy and Safety of First-line Etoposide/Platinum-based Chemotherapy Followed by Toripalimab Combined With Anlotinib for Maintenance in Extensive Small Cell Lung Cancer: A Single-arm, Multicentral Phase II Study
Our aim in this study was to evaluate the efficacy and safety of etoposide combined with cisplatin or carboplatin (EC/EP) chemotherapy regimens followed by toripalimab combined with anlotinib for maintenance in extensive small cell lung cancer(ES-SCLC).
Read the detailed description
Lung cancer is the most leading malignant tumor, among which small cell lung cancer accounts for about 15%. Approximately 65% of new patients were diagnosed with ES-SCLC at the first visit with less than 6 months of median PFS (mPFS) and 8-13 months of median OS (mOS). Platinum combined with etoposide or irinotecan chemotherapy is the first-line standard chemotherapy treatment. Despite high objective response of initial treatment, it is evitable to develop chemotherapy resistance and the effects of follow-up line treatment is dissatisfying. Therefore, combination therapy may be promising and efficient.
Anlotinib, the brand new multi-target protein tyrosine kinase (PTK) blockers, could normalize distribution of blood vessels in the tumor, gather T cells and enhance effect of immune drugs via vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), type Ⅲ tyrosine kinase and others signal pathways, and then inhibit the growth, proliferation and differentiation of lung cancer cells. According to ALTER1202 study, anlotinib played a promising role in local tumor control and effectively prolonged PFS in third line or more for ES-SCLC patients. Meanwhile, immunocheckpoint inhibitors can improve tumor immune microenvironment, relieve VEGF-mediated immunosuppression, reduce Treg activity, promote tumor antigen presenting ability and better infiltrate T cell into the tumor to play an anti-tumor effect. Emerging studies have shown that immunocheckpoint inhibitors, such as Atezolizumab, Pembrolizumab and Nivolumab, can effectively improve ORR, DoR and survival in SCLC patients. In terms of molecular mechanisms, immunocheckpoint inhibitors and vascular targeting drugs complemented and the combination of two drugs has superior efficacy in non-small cell lung cancer (NSCLC), just as it shown in IMpower150 and other studies. However, the role of immunocheckpoint inhibitors in maintenance therapy in SCLC were disappointing in CheckMate451 and a study of pembrolizumab, although it obtained some victories in first line or more for SCLC.
In summary, the investigators proposed that first-line etoposide/platinum-based chemotherapy followed by toripalimab combined with anlotinib for maintenance may prolong chemo-resistance in extensive small cell lung cancer.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Etoposide Injection, Carboplatin Injection, Cisplatin injection, Toripalimab, Anlotinib hydrochloride
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoposide InjectionDrug
Also called Etoposide
Etoposide(100mg/m2, d1-3, q3w) combined with platinum was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed.
Carboplatin InjectionDrug
Also called Carboplatin
Carboplatin(AUC 5, d1, q3w) or Cisplatin combined with etoposide was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed.
Cisplatin injectionDrug
Also called Cisplatin
Cisplatin(75mg/m2, d1, q3w) or carboplatin combined with etoposide was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed.
ToripalimabDrug
Also called JS001
After 4-6 cycles of chemotherapy, JS001(240mg, d1, q3w) combined with anlotinib were followed and continued until disease progression.
Anlotinib hydrochlorideDrug
Also called Anlotinib
After 4-6 cycles of chemotherapy, anlotinib(12mg qd, d1-14, q3w) combined with JS001 were followed and continued until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance group | Experimental | After 4-6 cycles of EP/EC chemotherapy regiment, maintenance therapy with toripalimab and anlotinib was followed and continued until disease progression. Receives: Drug: Etoposide Injection; Drug: Carboplatin Injection; Drug: Cisplatin injection; Drug: Toripalimab; Drug: Anlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS
Measured: Duration of time from the start of chemotherapy to the time of disease progression, assessed up to 3 years
Overall survival (OS)
OS
Measured: Duration of time from the start of chemotherapy to the time of outcome events, assessed up to 3 years
Secondary outcomes (4)
Adverse event (AE)
The acute and chronic AE profiles associated with the study regimen using CTCAE v5.0
Measured: Duration of time from the start of treatment to the end of study, assessed up to 3 years
Objective response rate (ORR)
ORR was the sum percentage of partial response (PR) and stable disease (SD) according to RECIST v1.1
Measured: Duration of time from the start of treatment to the end of study, assessed up to 3 years
Disease control rate (DCR)
DCR was the sum percentage of complete response (CR), partial response (PR) and stable disease (SD) according to RECIST v1.1
Measured: Duration of time from the start of treatment to the end of study, assessed up to 3 years
Duration of response (DoR)
DoR
Measured: Duration of time from the start of treatment response to the time of disease progression, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihua Yang, Taizhou Hospital
- Investigators
- Dongqing Lv, MD, Principal investigator, Enze Hospital affiliated Taizhou hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363255
- Sponsor's protocol ID
- LDQ-202004
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: make individual participant data (IPD) available
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of First-line Etoposide/Platinum-based Chemotherapy Followed by Toripalimab Combined With Anlotinib for Maintenance in Extensive Small Cell Lung Cancer: A Single-arm, Multicentral Phase II Study
- ClinicalTrials.gov ID
- NCT04363255
- Acronym / sponsor ID
- LDQ-202004
- Conditions
- Small Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 27 Apr 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.
Our aim in this study was to evaluate the efficacy and safety of etoposide combined with cisplatin or carboplatin (EC/EP) chemotherapy regimens followed by toripalimab combined with anlotinib for maintenance in extensive small cell lung cancer(ES-SCLC).
Detailed description
Lung cancer is the most leading malignant tumor, among which small cell lung cancer accounts for about 15%. Approximately 65% of new patients were diagnosed with ES-SCLC at the first visit with less than 6 months of median PFS (mPFS) and 8-13 months of median OS (mOS). Platinum combined with etoposide or irinotecan chemotherapy is the first-line standard chemotherapy treatment. Despite high objective response of initial treatment, it is evitable to develop chemotherapy resistance and the effects of follow-up line treatment is dissatisfying. Therefore, combination therapy may be promising and efficient.
Anlotinib, the brand new multi-target protein tyrosine kinase (PTK) blockers, could normalize distribution of blood vessels in the tumor, gather T cells and enhance effect of immune drugs via vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), type Ⅲ tyrosine kinase and others signal pathways, and then inhibit the growth, proliferation and differentiation of lung cancer cells. According to ALTER1202 study, anlotinib played a promising role in local tumor control and effectively prolonged PFS in third line or more for ES-SCLC patients. Meanwhile, immunocheckpoint inhibitors can improve tumor immune microenvironment, relieve VEGF-mediated immunosuppression, reduce Treg activity, promote tumor antigen presenting ability and better infiltrate T cell into the tumor to play an anti-tumor effect. Emerging studies have shown that immunocheckpoint inhibitors, such as Atezolizumab, Pembrolizumab and Nivolumab, can effectively improve ORR, DoR and survival in SCLC patients. In terms of molecular mechanisms, immunocheckpoint inhibitors and vascular targeting drugs complemented and the combination of two drugs has superior efficacy in non-small cell lung cancer (NSCLC), just as it shown in IMpower150 and other studies. However, the role of immunocheckpoint inhibitors in maintenance therapy in SCLC were disappointing in CheckMate451 and a study of pembrolizumab, although it obtained some victories in first line or more for SCLC.
In summary, the investigators proposed that first-line etoposide/platinum-based chemotherapy followed by toripalimab combined with anlotinib for maintenance may prolong chemo-resistance in extensive small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance group | Experimental | Drug: Etoposide Injection, Drug: Carboplatin Injection, Drug: Cisplatin injection, Drug: Toripalimab, Drug: Anlotinib hydrochlorideAfter 4-6 cycles of EP/EC chemotherapy regiment, maintenance therapy with toripalimab and anlotinib was followed and continued until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients must sign a specific informed consent form prior to clinical trial; 2. Extensive stage small cell lung cancer confirmed by histology or cytology; 3. Patients did not receive any system treatment before or only received EP/EC chemotherapy (time from the last medication of chemotherapy to the beginning of maintenance treatment must be ≤21 days); 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 5. An estimated survival duration of >5 months from the beginning of chemotherapy; 6. Age no less than 18; 7. A measurable lesion on image; 8. Patients with asymptomatic brain metastases or symptomatic brain metastases which were stable after treatment; 9. Before the first dose of drugs for study, patients should have appropriate organ function and the laboratory results must meet conditions as following: Blood routine examination: neutrophil absolute value (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin content (HGB) ≥9g/dl; Adequate hepatic function: bilirubin ≤1.5×ULN mg/dl, creatinine clearance ≥ 50 ml/min; Adequate hepatic function: Aspartate aminotransferase (AST) /alanine aminotransferase (ALT)> 2.5 × upper limit of normal (ULN) or > 5 × ULN (patients with liver metastasis), alkaline phosphatase (ALP) ≤2.5×ULN or ≤5×ULN (patients with bone metastasis), Total bilirubin (TB) ≤1.5×ULN, albumin (ALB)>30g/dl; Coagulation function: international normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN; Urine routine: 24-hour urine protein<1g (if urine protein ≥2+, additional 24-hour urine protein is required); Others: serum lipase or amylase ≤1.5×ULN or >1.5×ULN (subjects clinically or radiologically diagnosed with pancreatitis).
Key exclusion criteria (1 listed)
- 1. Patients received EP/EC regiment received the last medication ≥21 days before maintenance treatment, or received other systematic anti-tumor treatment for ES-SCLC; 2. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation; 3. Patients received any other experimental drugs or participated in another interventional clinical study within 4 weeks prior to signing the informed consent; 4. Patients received other systemic or local antitumor therapy (including but not limited to the use of other drugs for SCLC maintenance therapy or radiotherapy, but CR/PR subjects are allowed to use prophylactic cranial irradiation (PCI) after induction period treatment); 5. Patients with active and untreated brain metastases or carcinoma meningitis in CT or MRI examination during screening stage; 6. Patients with other malignant tumors within 5 years, except for curable malignant tumors (carcinoma in situ or stage I tumor), such as cervical carcinoma in situ, basal cell or squamous cell skin cancer and so on); 7. Patients received corticosteroids (>10mg/ day methyl prednisolone or equivalent dose) or other immunosuppressants (inhalation or local use of steroids and adrenal replacement treatment were permitted in the absence of an active autoimmune disease) less than 14 days prior to maintenance medications; 8. Patients with chronic or acute active hepatitis B (HBsAg positive and hepatitis B virus (HBV) DNA copy number >ULN), or HCV positive (HCV Ab positive and HCV RNA positive); Hepatitis B patients with previous HBV infection or who have been cured (HBsAg negative, HBcAb positive and HBV DNA copy number < ULN) were allowed to be enrolled; 9. Patients with interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or active pneumonia with clinical symptoms; or other lung diseases causing moderate or severe lung dysfunction; Active pulmonary tuberculosis or the need for anti-tuberculosis treatment; 10. Patients who were allergy to one of research drugs, or allergy to any one of the immunocheckpoint inhibitors or other platinum; 11. Female patients during pregnant and lactation period, or patients were plan to pregnant; 12. Patients with factors that may cause the study to be forced to terminate halfway according to investigators' judgement, such as poor compliance, other serious diseases requiring combined treatment and so on.
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 |
|---|---|---|
| Etoposide InjectionAlso: EtoposideEtoposide(100mg/m2, d1-3, q3w) combined with platinum was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed. | Drug | Maintenance group |
| Carboplatin InjectionAlso: CarboplatinCarboplatin(AUC 5, d1, q3w) or Cisplatin combined with etoposide was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed. | Drug | Maintenance group |
| Cisplatin injectionAlso: CisplatinCisplatin(75mg/m2, d1, q3w) or carboplatin combined with etoposide was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed. | Drug | Maintenance group |
| ToripalimabAlso: JS001After 4-6 cycles of chemotherapy, JS001(240mg, d1, q3w) combined with anlotinib were followed and continued until disease progression. | Drug | Maintenance group |
| Anlotinib hydrochlorideAlso: AnlotinibAfter 4-6 cycles of chemotherapy, anlotinib(12mg qd, d1-14, q3w) combined with JS001 were followed and continued until disease progression. | Drug | Maintenance group |
Primary outcome
Progression free survival (PFS)
Time frame: Duration of time from the start of chemotherapy to the time of disease progression, assessed up to 3 years
PFS
Overall survival (OS)
Time frame: Duration of time from the start of chemotherapy to the time of outcome events, assessed up to 3 years
OS
4 secondary outcomes
Adverse event (AE)
Time frame: Duration of time from the start of treatment to the end of study, assessed up to 3 years
Objective response rate (ORR)
Time frame: Duration of time from the start of treatment to the end of study, assessed up to 3 years
Disease control rate (DCR)
Time frame: Duration of time from the start of treatment to the end of study, assessed up to 3 years
Duration of response (DoR)
Time frame: Duration of time from the start of treatment response to the time of disease progression, assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No. make individual participant data (IPD) available
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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.
Dongqing Lv, MD principal investigator
Enze Hospital affiliated Taizhou hospital of Wenzhou Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etoposide Injection, Carboplatin Injection and Cisplatin injection in people with Small Cell Lung Carcinoma, run by Taizhou Hospital at 2 sites 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 1 inclusion and 1 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Dongqing Lv, MD (13867622009, lvdq@enzemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Duration of time from the start of chemotherapy to the time of disease progression, assessed up to 3 years). The study lists 2 primary outcomes in all. 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 28 Apr 2020.