Download Lung cancer trials

Lung cancer trials:
Past, present and future
Eleanor Aynsley
Lung NSSG meeting
May 2011
Past







BTOG2
Gelcaps
INCH
LU22
SOCCAR
Study 12
Topical
BTOG2


In NSCLC stage IIIB/IV
Phase III randomised trial
Gemcitabine + cisplatin at 80mg/m2
 Gemcitabine + cisplatin at 50mg/m2
 Gemcitabine + carboplatin AUC6


1350 total recruited (closed Nov 2009)

N Cumbria 4, Newcastle 9, North Durham 7, North Tyneside 3,
Gateshead 6, Sunderland 10, Wansbeck 8 (47 total)
Gelcaps



Genetic Lung Cancer Predisposition Study: a molecular
epidemiology study
Observational Study
Eligibility




A All patients diagnosed with lung cancer
B Partner of above who has not developed a smoking related
malignancy
Closed 2004, 6000 patients recruited
Locally:


16 North Tees
78 South Tees
INCH




Randomised Phase II/III trial of induction
chemotherapy followed by CHART vs.. CHART alone
in NSCLC
Important question as evidence CHART superior to
conventional RT, but also that chemotherapy beneficial
when combined with RT
Closed 2007, only accrued 9% total (aimed for 500)
2 patients recruited in Durham
LU 22
The Lancet,Vol. 369 Issue 9577, Pages 1929 - 1937, 9 June 2007






11 patients recruited at North Tees
A Randomised Trial of Surgical Resection With or Without PreOperative Chemotherapy in Patients With Operable Non-Small
Cell Lung Cancer (NSCLC) of any Stage
Phase III trial
519 patients recruited from 70 centres in UK, Netherlands,
Germany and Belgium, closed 2005
Randomised to surgery alone or 3 cycles of platinum based
chemo (MVP, MIC, Carbo-taxol, Gem-Cis or Doc-Carbo)
Primary outcome measure overall survival
LU22




61% stage I, 31% stage II, and 7% stage III
75% received 3 cycles
48% of patients receiving chemotherapy had CR
or PR, and 28% stable disease, 2% PD, 21% not
assessed after chemotherapy (some progressed
during chemotherapy)
92% proceeded to surgery
LU22



No increase in postoperative complications
No increased impairment
in quality of life
But no increase in overall
survival or PFS, but ?too
small a trial as relatively
low numbers of events
SOCCAR




Randomised phase III trial of sequential
chemotherapy followed by radiotherapy vs.
concurrent chemoradiotherapy in inoperable
stage III NSCLC
Chemotherapy cisplatin and vinorelbine,
radiotherapy 55Gy in 20#
Closed 2009 with 100% recruitment
7 patients recruited in Newcastle 5 in South
Tees
Study 12




Phase III trial randomised double blind placebo
controlled trial of carboplatin and etoposide
with or without thalidomide in SCLC
720 recruited (100%), closed 2006
Showed no increased benefit from thalidomide
and an increased risk of thrombosis
1 patient recruited in South Tees, 3 UHND, 2
North Tyneside, 5 Sunderland, 1 Wansbeck
Topical





Phase III trial of Tarceva or placebo in advanced
NSCLC in patients unsuitable for chemotherapy (1st
line)
J Clin Oncol 28:15s, 2010 (suppl; abstr 7504)
No increase in OS, some increase in PFS, especially for
women and adenocarcinomas
664 patients recruited (100%), closed 2009
4 patients recruited South Tees, 4 North Tyneside, 4
UHND, 4 Sunderland, 3 Wansbeck
Present






Convert
Fragmatic
LungStar
MALCS
Quartz
REST
Convert





Phase III trial of limited stage small cell lung cancer of
concurrent chemoradiotherapy
Open JCUH and NCCC (1 recruited in each so far)
Aim to recruit 532 patients (38%), due to close January
2012
Control arm 4-6 cycles of cisplatin and etoposide with
concurrent BD RT 45Gy in 30 fractions over 3 weeks,
5 days per week from day 22 of cycle 1
Experimental arm 4-6 cycles of cisplatin and etoposide
with concurrent OD RT 66Gy in 33 fractions
Fragmatic





Phase III trial investigating effect of Fragmin (dalteparin) added
to standard therapy in patients with lung cancer
Open to any histologically confirmed lung cancer patients willing
to have daily injection themselves or via carer
If randomised to dalteparin to start within 6 weeks of diagnosis
and before start treatment
Aim to recruit 2200, so far 78% and closes January 2012
58 recruited in the network (4 UHH, 11UHNT, 7JCUH,
6BAGH, 3DMH, 1 NCCC, 5 QEH, 8 Wansbeck, 2 SRH, 8
STDH)
LungStar


Phase III double blind placebo controlled trial
of pravastatin added 1st line chemotherapy for
Small Cell lung cancer
Aiming for 1300, 53% recruited: locally 1JCUH,
1 UHND, 1 STDH
MALCS
(Mesothelioma and Lung Cancer Study)


Population based case control study in relation
to occupation in British men and women under
the age of 60 (looking at asbestos exposure)
Aim to recruit 3000, 47% so far: 13 UHNT, 2
JCUH, 1 DMH, 7 NCAT, 3 STDH
QUARTZ



Quartz
Phase III RCT to assess with optimal supportive
care (including dexamethasone) alone is as
effective as OSC plus WBRT in the treatment of
patients with inoperable brain metastases from
NSCLC
Provisional results no difference in OSC arm
Aim to recruit 534, 45% so far: locally 9
recruited
REST




Phase III trial comparing
thoracic RT vs. no
thoracic RT in extensive
stage small cell lung
cancer
CR or PR to initial
chemotherapy
Aim to recruit 483, so far
37%
Now open JCUH
Future




CHART-ED
ET
Lung-ART
Modafinil
CHART-ED




Phase I study to assess the feasibility of
radiotherapy dose escalation for treating patients
with inoperable stage III NSCLC.
Aim to recruit 18 patients by 31st July, then to
open phase II study of dose-escalated CRT with
CHART-ED schedule
66% recruited to date
Open Newcastle
ET trial


ERCC1: excision repair
cross-complementation
group 1 repairs platinum
induced DNA damage
Aim to recruit 1272
patients 12% so
far
Lung-ART



Phase III study comparing post operative
radiotherapy to no post-op RT in completely
resected NSCLC with N2 nodal involvement
Can have adjuvant chemotherapy prior
Dose 54Gy in 27 to 30#
Modafinil








Novel CNS stimulant with more selective activity in the brain
and therefore fewer side effects.
Fatigue is common in lung cancer patients
Phase IV randomised double-blind placebo controlled trial
Aim to recruit 206 patients over 18 months
Patients with incurable NSCLC who report fatigue
Cannot have received chemotherapy or radiotherapy in the past
4 weeks, or be on a TKI
Cannot have commenced antidepressants or steroids in the last 2
weeks
Cannot have had a blood transfusion in the last 2 weeks
Thank you