Non-small Cell Lung CancerPhase 2PINNCT01788332
Parp Inhibitor in Advanced Non-Small Cell Lung Cancer (PIN)
A Phase 2 study testing Olaparib in people with Non-small Cell Lung Cancer, run by Lisette Nixon at 20 sites in United Kingdom.
Trial summary
In 2010, more than 35,000 people died in the United Kingdom from lung cancer, the majority from non-small cell cancer (NSCLC). Chemotherapy is one of the main treatments for patients with NSCLC but those treated will still only live for an average of 9 or 10 months after diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Olaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 20 sitesUnited Kingdom
- Study dates
- Jan 2014to Dec 2018
- 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
- Histological diagnosis of NSCLC. Histology can be either squamous or non-squamous.
- Stage IIIB or stage IV lung cancer that is not amenable to curative therapy.
- Have had no prior systemic chemotherapy for advanced NSCLC. Previous adjuvant or neoadjuvant chemotherapy for non-advanced disease is acceptable. Prior treatment with an oral targeted therapy for e.g. EGFR/ALK or other driver- oncogene mutated lung cancer is allowed. Immunotherapy e.g. with a PD1 or PDL1 targeted agent is allowed.
- Patients who have already started their induction chemotherapy are not eligible for stage 1 of the trial
- Eligible to receive standard platinum doublet-based chemotherapy.
- Men or women, aged 18 or over and capable of giving informed consent.
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- Willing to consent to provide tissue and blood for translational research.
- Informed consent prior to any study specific procedures.
- Confirmed diagnosis of NSCLC (either squamous or non-squamous). Stage IIIB or stage IV that is not amenable to curative therapy.
- ECOG performance status 0-1
- Evidence of radiological response to induction chemotherapy, from the pre-treatment to baseline. This can include mixed stable/response or evidence of tumour shrinkage that does not reach the criteria of partial response according to RECIST.
- Have had no prior systemic chemotherapy for advanced NSCLC. Previous adjuvant or neoadjuvant chemotherapy for non-advanced disease is acceptable. Previous palliative radiotherapy to non-target metastases is allowed provided no more than 25% of the bone marrow volume is irradiated. Irradiated sites cannot include the sites of measurable disease unless clear tumour progression has been documented in them since the end of radiation therapy. Patients who have had adjuvant therapy and then progressed after a year of completing adjuvant therapy are eligible. Patients who have received an oral inhibitor for molecularly stratified subgroups e.g. EGFR or ALK mutated lung cancer, are allowed. Immunotherapy e.g. with a PD1 or PDL1 targeted agent is allowed.
- Adequate organ function, including the following:
- Adequate bone marrow reserve: White cell count ≥ 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, haemoglobin ≥ 90g/L.
- Hepatic: total bilirubin ≤ 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≤ 2.5 x ULN. ALP, AST, and ALT ≤ 5 x ULN is acceptable if the liver has tumour involvement.
- Renal: calculated creatinine clearance (CrCl) ≥ 50mL/min using Cockcroft-Gault or Wright formula, serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN).
- If blood count/morphology suggestive of MDS/AML, no features suggestive of MDS/AML on peripheral blood smear.
- Patients with reproductive potential (male or female), who are sexually active for the duration of the trial or the drug washout period, should be prepared to use two effective forms of contraception.
- Men or women, aged 18 or over.
- Willing to consent to provide tissue and blood for translational research.
- Patients must provide informed consent prior to any study specific procedures.
- There should be no more than 42 days between day 1 of the last cycle of induction chemotherapy and starting Olaparib/placebo.
Who cannot join
- Evidence of small cell, large cell neuroendocrine or carcinoid histology.
- Have a serious or uncontrolled medical condition that could compromise the patients' ability to adhere to the protocol.
- Have a secondary malignancy (except adequately treated non-melanomatous skin cancer, or other cancer considered cured by surgical resection or radiation). Patients who have had another malignancy in the past but have been disease free for more than 5 years are eligible.
- Previous treatment with PARP inhibitors
- Uncontrolled gastrointestinal disorders such as active diverticulitis or colitis, or any major GI resection which could have an impact on patients' ability to absorb Olaparib.
- Myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
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- Evidence of small cell, large cell neuroendocrine or carcinoid histology.
- Patients with radiological disease progression or stable disease after induction chemotherapy
- Have received treatment with an agent that has not received regulatory approval, within 30 days of study entry.
- Have had a blood transfusion within 28 days prior to commencing Olaparib or have a WBC <3 x 109/L
- Have received yellow fever vaccination in the 30 days prior to randomisation.
- Difficulty swallowing.
- Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases e.g. involving complete surgical removal or radical radiotherapy to a solitary CNS metastasis). A
- Concurrent administration of any other systemic antitumour therapy.
- Have a serious or uncontrolled medical condition that would compromise the patient's ability to adhere to the protocol.
- Diagnosis of a second malignancy (except adequately treated non-melanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation). Patient who had another malignancy in the past but have been disease free for more than 5 years are eligible.
- Previous treatment with PARP inhibitors.
- Uncontrolled gastrointestinal disorders such as active diverticulitis or colitis, or any major GI resection which could have an impact on patients' ability to absorb Olaparib.
- Myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
- Pregnant or breastfeeding.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United Kingdom20 sites
Blackpool Victoria Hospital
Blackpool
Bradford Royal Infirmary
Bradford
Queen's Hospital
Burton-on-Trent
Velindre Cancer Centre
Cardiff
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
Derby Teaching Hospitals NHS Foundation Trust
Derby
Beatson West of Scotland Cancer Centre
Glasgow
Withybush General Hospital
Haverfordwest
Huddersfield Royal Infirmary
Huddersfield
University Hospitals of Morecambe Bay
Lancashire
St James University Hospital
Leeds
Leicester Royal Infirmary
Leicester
Charing Cross Hospital
London
The Christie NHS Foundation Trust
Manchester
The James Cook University Hospital
Middlesbrough
Royal Preston Hospital
Preston
Weston Park Hospital
Sheffield
University Hospitals of North Midlands
Stoke-on-Trent
Singleton Hospital
Swansea
Wrexham Maelor Hospital
Wrexham
About this study
Official title: A Randomised Phase II Trial of Olaparib Maintenance Versus Placebo Monotherapy in Patients With Chemosensitive Advanced Non-Small Cell Lung Cancer
In 2010, more than 35,000 people died in the United Kingdom from lung cancer, the majority from non-small cell cancer (NSCLC). Chemotherapy is one of the main treatments for patients with NSCLC but those treated will still only live for an average of 9 or 10 months after diagnosis.
The purpose of this clinical trial is to find out whether or not giving a drug called Olaparib following chemotherapy will benefit patients with NSCLC who have responded to initial chemotherapy treatment by prolonging the time before the tumour regrows. Olaparib is a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. The rationale for this clinical trial is that chemotherapy damages tumour cell DNA and NSCLC tumours that respond to chemotherapy are less able to repair this damage. This can be exploited by using Olaparib as it blocks an enzyme called Poly (ADP-ribose) polymerase (PARP) which is essential for DNA repair. This will prevent DNA repair and cause cancer cell death by a mechanism known as synthetic lethality. Synthetic lethality arises when a combination of mutation in two or more genes leads to cell death.
Up to 300 patients who are to receive standard chemotherapy treatment will be initially registered into the trial. Of these patients, 114 patients who have responded to chemotherapy will be randomly allocated to receive either Olaparib or an inactive dummy pill or placebo by mouth. The trial will assess whether Olaparib delays disease progression following standard chemotherapy treatment in patients. It will also show whether the side effects of adding Olaparib following standard treatment are acceptable.
Read the detailed description
This is a multicentre randomised phase II trial. Patients are initially registered either before or during induction chemotherapy, their response to which will be used to determine whether they are eligible for randomisation. All patients will be asked to consent to archival tissue collection for translational analysis and to provide a translational blood sample. The second consent will precede randomisation to one of two groups of maintenance therapy (olaparib or placebo) with 1:1 randomisation if they have had an objectively measured complete or partial response following standard chemotherapy.
Randomised patients will receive olaparib or placebo until disease progression. They will be monitored by CT scan every two cycles until disease progression, where they will be managed according to local practice. Follow up will be for a maximum of 12 months from the point of randomisation or until disease progression.
All randomised patients for whom we have a baseline translational blood sample will be asked to provide a follow up blood sample upon randomisation and again at radiological progression. Registered patients with progressive disease after the initial induction chemotherapy will be asked to provide a follow-up blood sample at the end of induction chemotherapy.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Olaparib, Placebo
- Keywords
- NSCLC, non-small cell, lung cancer
- 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.
OlaparibDrug
Also called AZD2281, KU-0059436
Olaparib is a potent inhibitor of poly (ADP-ribose) polymerase enzyme (PARP), (molecular weight 434) that is being developed as a monotherapy as well as for combination with chemotherapy and other anti-cancer agents. Olaparib can lead to tumour regression in patients with DNA repair deficient NSCLC. Olaparib may also enhance the DNA damaging effects of chemotherapy.
PlaceboOther
3 100mg tablets to be administered twice a day with approximately 240ml of water
| Study group | Role | What they receive |
|---|---|---|
| Olaparib | Active comparator | 3 100mg tablets to be administered twice a day with approximately 240ml of water. Receives: Drug: Olaparib |
| Placebo | Placebo comparator | 3 100mg tablets to be administered twice a day with approximately 240ml of water. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
To establish the anti-tumour activity of Olaparib (measured by progression free survival),we will document the time from randomisation to any disease progression and/or death, defined according to strict RECIST (Response Evaluation Criteria in Solid Tumours) v1.1. Lesions will be compared to baseline measurements to assess progression.
Measured: 72 weeks
Secondary outcomes (6)
Safety
An Independent Data Monitoring Committee will convene and assess safety when 10 and 20 patients on each arm have completed trial treatment. If the trial is deemed safe to continue then safety will be assessed again approximately every six months. Toxicity data will be assessed along with serious adverse events.
Measured: 72 weeks
Objective response rate
This will be assessed based on radiological disease progression defined according to RECIST (Response Evaluation Criteria in Solid Tumours) v1.1.
Measured: 72 weeks
Overall survival
This will be calculated from the time of randomisation to date of death or date last known to be alive.
Measured: 72 weeks
Change in tumour volume reduction
Change in tumour volume reduction from randomisation to 6 months
Measured: 27 weeks
Tolerability
This will be assessed in terms of the number of treatment reductions, delays and withdrawals.
Measured: 72 weeks
Feasibility
Patients will complete a diary card every day to document compliance. Feasibility of use will also be assessed in terms of number of treatment reductions, delays and withdrawals.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisette Nixon
- Sponsor type
- Other government
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Lisette Nixon, Velindre NHS Trust
- Investigators
- Dean Fennell, Professor, Study chair, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788332
- Sponsor's protocol ID
- PIN
- Acronym
- PIN
- Status last verified
- Oct 2018
- First submitted
- 4 Feb 2013
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fennell DA, Porter C, Lester J, Danson S, Blackhall F, Nicolson M, Nixon L, Gardner G, White A, Griffiths G, Casbard A. Olaparib maintenance versus placebo monotherapy in patients with advanced non-small cell lung cancer (PIN): A multicentre, randomised, controlled, phase 2 trial. EClinicalMedicine. 2022 Aug 11;52:101595. doi: 10.1016/j.eclinm.2022.101595. eCollection 2022 Oct.
PubMed 35990583
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II Trial of Olaparib Maintenance Versus Placebo Monotherapy in Patients With Chemosensitive Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01788332
- Acronym / sponsor ID
- PIN / PIN
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, non-small cell, lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Lisette NixonOther government
- Collaborators
- AstraZeneca
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Feb 2013 (estimated)
- 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.
In 2010, more than 35,000 people died in the United Kingdom from lung cancer, the majority from non-small cell cancer (NSCLC). Chemotherapy is one of the main treatments for patients with NSCLC but those treated will still only live for an average of 9 or 10 months after diagnosis.
The purpose of this clinical trial is to find out whether or not giving a drug called Olaparib following chemotherapy will benefit patients with NSCLC who have responded to initial chemotherapy treatment by prolonging the time before the tumour regrows. Olaparib is a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. The rationale for this clinical trial is that chemotherapy damages tumour cell DNA and NSCLC tumours that respond to chemotherapy are less able to repair this damage. This can be exploited by using Olaparib as it blocks an enzyme called Poly (ADP-ribose) polymerase (PARP) which is essential for DNA repair. This will prevent DNA repair and cause cancer cell death by a mechanism known as synthetic lethality. Synthetic lethality arises when a combination of mutation in two or more genes leads to cell death.
Up to 300 patients who are to receive standard chemotherapy treatment will be initially registered into the trial. Of these patients, 114 patients who have responded to chemotherapy will be randomly allocated to receive either Olaparib or an inactive dummy pill or placebo by mouth. The trial will assess whether Olaparib delays disease progression following standard chemotherapy treatment in patients. It will also show whether the side effects of adding Olaparib following standard treatment are acceptable.
Detailed description
This is a multicentre randomised phase II trial. Patients are initially registered either before or during induction chemotherapy, their response to which will be used to determine whether they are eligible for randomisation. All patients will be asked to consent to archival tissue collection for translational analysis and to provide a translational blood sample. The second consent will precede randomisation to one of two groups of maintenance therapy (olaparib or placebo) with 1:1 randomisation if they have had an objectively measured complete or partial response following standard chemotherapy.
Randomised patients will receive olaparib or placebo until disease progression. They will be monitored by CT scan every two cycles until disease progression, where they will be managed according to local practice. Follow up will be for a maximum of 12 months from the point of randomisation or until disease progression.
All randomised patients for whom we have a baseline translational blood sample will be asked to provide a follow up blood sample upon randomisation and again at radiological progression. Registered patients with progressive disease after the initial induction chemotherapy will be asked to provide a follow-up blood sample at the end of induction chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olaparib | Active comparator | Drug: Olaparib3 100mg tablets to be administered twice a day with approximately 240ml of water. |
| Placebo | Placebo comparator | Other: Placebo3 100mg tablets to be administered twice a day with approximately 240ml of water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histological diagnosis of NSCLC. Histology can be either squamous or non-squamous.
- Stage IIIB or stage IV lung cancer that is not amenable to curative therapy.
- Have had no prior systemic chemotherapy for advanced NSCLC. Previous adjuvant or neoadjuvant chemotherapy for non-advanced disease is acceptable. Prior treatment with an oral targeted therapy for e.g. EGFR/ALK or other driver- oncogene mutated lung cancer is allowed. Immunotherapy e.g. with a PD1 or PDL1 targeted agent is allowed.
- Patients who have already started their induction chemotherapy are not eligible for stage 1 of the trial
- Eligible to receive standard platinum doublet-based chemotherapy.
Key exclusion criteria (20 listed)
- Evidence of small cell, large cell neuroendocrine or carcinoid histology.
- Have a serious or uncontrolled medical condition that could compromise the patients' ability to adhere to the protocol.
- Have a secondary malignancy (except adequately treated non-melanomatous skin cancer, or other cancer considered cured by surgical resection or radiation). Patients who have had another malignancy in the past but have been disease free for more than 5 years are eligible.
- Previous treatment with PARP inhibitors
- Uncontrolled gastrointestinal disorders such as active diverticulitis or colitis, or any major GI resection which could have an impact on patients' ability to absorb Olaparib.
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 |
|---|---|---|
| OlaparibAlso: AZD2281, KU-0059436Olaparib is a potent inhibitor of poly (ADP-ribose) polymerase enzyme (PARP), (molecular weight 434) that is being developed as a monotherapy as well as for combination with chemotherapy and other anti-cancer agents. Olaparib can lead to tumour regression in patients with DNA repair deficient NSCLC. Olaparib may also enhance the DNA damaging effects of chemotherapy. | Drug | Olaparib |
| Placebo3 100mg tablets to be administered twice a day with approximately 240ml of water | Other | Placebo |
Primary outcome
Progression-free survival
Time frame: 72 weeks
To establish the anti-tumour activity of Olaparib (measured by progression free survival),we will document the time from randomisation to any disease progression and/or death, defined according to strict RECIST (Response Evaluation Criteria in Solid Tumours) v1.1. Lesions will be compared to baseline measurements to assess progression.
6 secondary outcomes
Safety
Time frame: 72 weeks
Objective response rate
Time frame: 72 weeks
Overall survival
Time frame: 72 weeks
Change in tumour volume reduction
Time frame: 27 weeks
Tolerability
Time frame: 72 weeks
Feasibility
Time frame: 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Derived from this study: PubMed 35990583Fennell DA, Porter C, Lester J, Danson S, Blackhall F, Nicolson M, Nixon L, Gardner G, White A, Griffiths G, Casbard A. Olaparib maintenance versus placebo monotherapy in patients with advanced non-small cell lung cancer (PIN): A multicentre, randomised, controlled, phase 2 trial. EClinicalMedicine. 2022 Aug 11;52:101595. doi: 10.1016/j.eclinm.2022.101595. eCollection 2022 Oct.
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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.
Dean Fennell, Professor study chair
University of Leicester
20 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 Olaparib in people with Non-small Cell Lung Cancer, run by Lisette Nixon at 20 sites in United Kingdom.
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 22 inclusion and 20 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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Progression-free survival (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01788332, which also lists 1 linked publication.
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 26 Oct 2018.